Medical Device Regulatory Landscape Discussed in Post AdvaMed MedTech Wrap Up

Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways that allow the industry to grow and flex along with innovation. Still based in sound science and documented evidence, FDA expects sponsor and contract manufacturers to tighten controls over raw materials and component quality equal to internal design and production. Now more than ever companies must plan and prepare for meeting quality requirements and ensure quality measures are weaving design, supporting technologies, supply chain and feedback mechanisms into one cohesive program.

Pharma’s Problems with Data Integrity

Presented by Independent Consultant, Brian Nadel

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity, or lack thereof, can have major repercussions for a firm because once FDA finds some data to be unreliable, it considers all of a firms’ data to be unreliable. FDA expects that data to be reliable and accurate, and that crucial and often overlooked validation step can ultimately cost manufacturers untold amounts in R&D, materials, product recalls, submissions, and more.

Understand the Agency’s expectations of data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.

Foreign Supplier Verification and How to Protect Your Business

Presented for NCBFAA

The FSVP requires importers to be proactive, to verify that food they import is safe. This is a huge burden for many Importers and no less so for FDA. FDA's recently increased number of inspections of importers to evaluate their compliance with FSVP requirements is a reflection of FDA's commitment to make FSVP work. FDA inspections are also revealing that a significant number of importers do not understand what is needed to comply nor how. Customs brokers and freight forwarders, if not importers themselves, can help clients know what FDA is looking for, and who can assist them.

Fill out the form to get a download link for the Supplier Evaluation Worksheet

“Own Label Distributor” Responsibilities

More and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services. This requires a full understanding of how those contract services are being conducted in order to have complete confidence that their products are meeting quality specifications and regulatory requirements. In addition in the past several years, the FDA has focused more intensely on such companies that they refer to as “own label distributors” (“OLDs”). The result has been an escalating number of FDA inspections, Form 483 inspection observations, and warning letters.

With such increasing FDA enforcement activity, it is imperative that those in responsible positions in OLDs gain a full understanding of FDA’s requirements for “knowing what and how these [contracted] activities are performed so that you can make decisions — whether to approve and release the products for distribution”. This also means that you are “responsible for ensuring that the product is not adulterated for failure to comply with CGMP requirements, regardless of who actually performs the CGMP operations”.

This webinar will include the following topics:

  • FDA’s Explanation of the Responsibilities of an “Own Label Distributor
  • How To Meet Your “OLD” Responsibilities
  • Qualifying Contract Service Providers
  • Establishing a Quality Agreement With a Contract Service Provider
  • Responsibilities of an “OLD’s” Quality Unit
  • Key SOPs/Documents & Recommended Content
  • On-Going Monitoring of a Contract Manufacturer/Packager

Time for an interactive Q&A period will be provided at the end of the presentation.

About the presenter

Bruce Elsner

EAS Independent Consultant, Bruce Elsner, has over 28 years of experience working in FDA regulated fortune 250 companies manufacturing and packaging drug, medical device, and cosmetic products. His responsibilities have included laboratory management, process control and improvement, pilot plant management, plant quality assurance management and quality systems improvement across multiple manufacturing and research facilities. He has been consulting for OTC drug and dietary supplement companies for more than 22 years in the areas cGMP compliance auditing and quality systems improvement. His experience also includes training drug and dietary supplement industry personnel in cGMP requirements, assisting in improving their levels of compliance with those regulations and helping them respond to complex issues arising from FDA inspection observations, warning letters and consent decrees.

Preparing for Tobacco TPMPs in Cooperation with TMA

Since CTP Director, Mitch Zeller’s announcement at the 2018 TMA Annual Meeting that the Agency is prioritizing a Tobacco Product Manufacturing Practices Rule (TPMPs), the industry has been speculating regarding what these rules may encompass.

While there has been no direct guidance from the FDA to date on what may be included in a TPMP rule, some insight can be gained from the results of the numerous tobacco industry inspections that the Agency has performed over the past 6 years. Based on these inspections there are likely to be numerous requirements regarding TPMPs.

Hosted in Cooperation with the Tobacco Merchants Association, this informative webinar will provide an overview of expectations for the TPMP rule and how you can begin assessing your current quality systems.

The tobacco industry should now be performing manufacturing and quality process assessments to prepare for the development and implementation of quality systems, manufacturing and packaging controls, facilities management, material controls, equipment qualification and calibrations, equipment cleaning and maintenance processes, sanitation and environmental monitoring programs, and a personnel training program; all of which is governed by written procedures (SOPs) and documented via the generation of records. Based on Mr. Zeller’s presentation, the impending issuance of Tobacco TPMPs in conjunction with FDA’s inspectional activities indicates this preparation should begin sooner rather than later.

About the Presenters

Dean Cirotta

Dean Cirotta is the President and Chief Operating Officer for EAS Consulting Group where he is responsible for the day to day management of the technical aspects of the company with responsibility for client relations and personnel management. Mr. Cirotta is a highly accomplished Executive with 29 years of experience in the pharmaceutical and dietary supplement industries, including executive management roles with responsibility for regulatory affairs, compliance, quality assurance/control, operations, manufacturing, laboratory operations, and financial and corporate management. Mr. Cirotta works with Pharmaceutical, Dietary Supplement and Tobacco companies to ensure compliance with all applicable FDA laws and regulations. Immediately prior to joining EAS, Mr. Cirotta was President and COO of UPM Pharmaceuticals in Baltimore, Md. and prior to UPM, he was Vice President of Global Regulatory Affairs for the pharmaceutical division of Bausch & Lomb.

Tara Lin Couch, Ph.D.

EAS Senior Director for Dietary Supplement and Pharmaceutical Services, Dr. Tara Lin Couch, is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.


EAS Presents at United Nations to SIDS DOCK Assembly

For Immediate Release
EAS Consulting Group, LLC Alexandria, VA

October 5, 2018: EAS Consulting Group, LLC Announces Collaboration with Small Islands and Presents on FDA Regulatory Services to Fourth Session of the SIDS DOCK Assembly at the United Nations Headquarters

Dean Cirotta presenting at U.N. Assembly. Photo Credit: @gregmorrisphotographer

EAS Consulting Group is honored to announce that Dean Cirotta, EAS President and COO, was an invited key speaker to the September 29, 2018 Fourth Session of the SIDS DOCK Assembly – the Sustainable Energy and Climate Resilience Organization, at the United Nations Headquarters in New York City, to discuss EAS regulatory capabilities in support of 32 small islands and low lying nations seeking to export US Food and Drug Administration (US FDA) regulated raw material ingredients and products into the United States.

Speaking to Her Excellency Ms. Keisha A. McGuire, Esq., Ambassador and Permanent Representative of Grenada to the United Nations, and the newly-elected Chair for the SIDS DOCK Island Women Open Network (IWON), who sat interim for the newly-elected President of the Assembly, His Excellency Dr. The Right Honourable Keith C. Mitchell, Prime Minister of Grenada; His Excellency, Dr. Albert Binger, Secretary-General of SIDS DOCK; His Excellency Mr. Ronald Jumeau, Ambassador and Permanent Representative of the Republic of the Seychelles to the United Nations and newly-elected Chair of the SIDS DOCK Executive Council; Her Excellency Ms. I. Rhonda King, Ambassador and Permanent Representative of St. Vincent and the Grenadines to the United Nations, former Chair of the SIDS DOCK IWON, and the newly-elected Seventy-Fourth President of the United Nations Economic and Social Council (ECOSOC), and other distinguished delegates and special guests in attendance, Mr. Cirotta discussed EAS’s capability and capacity to support the Island Nations and specifically the Island Women Open Network’s (IWON) Herbal/Botanical initiative with an understanding of and compliance assistance with FDA export and sales requirements of herbal and botanical ingredients and products into the US and other global regions.

The SIDS DOCK IWON Pilot Initiative on Developing a Successful Natural Products Industry: Quality, Claims, Cyber and Intellectual Property, is the signature project for the SIDS DOCK Organization, and is being coordinated by Ms. Heather Fairman, SIDS DOCK IWON Advisor and Technical Coordinator for the Herbal/Botanical Project, who has 30 years of experience in the industry. Ms. Fairman, who also serves as an Independent Consultant for EAS, saw the tremendous value that EAS’s unique regulatory and scientific expertise and knowledge could provide in support of the development of the industry for the SIDS. As such, Ms. Fairman was responsible for introducing and orchestrating EAS’s partnership with the SIDS DOCK organization.

Of keen interest to the Assembly was Mr. Cirotta’s explanation of EAS’s specialization in US FDA regulatory matters with a prime focus of assisting domestic and foreign firms with compliance to the applicable US FDA laws and regulations. He went on to highlight that EAS is staffed with former FDA compliance and inspection officials and industry executives and is assisted by a global network of 150 independent consultants, hand-chosen for their expertise in a variety of technical areas.

According to Dr. Al Binger, Secretary General of the SIDS DOCK, “EAS ‘s unique consulting capabilities as described by Mr. Cirotta to include “facility registrations, product listings, label reviews, test methods review and development, ingredient acceptability, new ingredient evaluation and approval, the development and implementation of quality systems to meet FDA Good Manufacturing Practices (GMPs), along with the appropriate training from “farm to fork” and the preparation for foreign FDA inspections”, can be considered as part of the recipe for success for the Herbal/Botanical project in small island states.”.

(L-R): Heather Fairman, Lisa Cirotta, Dean Cirotta, Tara Lin Couch, Ph.D. Photo Credit: @gregmorrisphotographer

Dean Cirotta was accompanied at the U.N. by EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. who oversees EAS’s Quality Control efforts in dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. She assists numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations.

For more information on EAS Consulting Group visit

FDA Announces Export Certifications and Fees for Certain Food Products

By Charles Breen, Independent Advisor for FSMA

On August 31, 2018, FDA announced a new voluntary export certification option for certain foods as authorized under FSMA, similar to that available for qualified pharmaceuticals and medical devices. This new export certification program and its associated fees will allow the agency to collect up to $175 for export certifications for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The issuance and collection of these fees begin October 1, 2018, and are in effect for two new types of food certificates, the “Certificate to a Foreign Government” and “Certificate of Exportability.”

Prior to this announcement, CFSAN issued only a “Certificate of Export” for seafood, food additives, and food contact substances and a “Certificate of Free Sale” for foods other than seafood, dietary supplements, infant formula, medical foods, and foods for special dietary use.

Per the FDA’s Constituent Update, the “Certificate to a Foreign Government” will be available for products that meet the applicable requirements of the FD&C Act and will certify that a product (or products) may be marketed in and legally exported from the United States. The “Certificate of Exportability” will be available for export only products and will certify that a product or products meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. FDA anticipates that the new certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by FDA of FDA-regulated food products.

Requests for written export certification for FDA regulated products are common from foreign customers or foreign governments. In the case of food products, FDA provides, though does not require, written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Those U.S. companies which export foods are required to follow U.S. laws and regulations as well as those specific to the countries the products are being exported to. It is important to note that laws vary across countries and FDA does not provide any guidance for laws outside of the U.S. that companies must follow.

Most CFSAN export certificates may be obtained by completing an online application through the FDA Unified Registration and Listing Systems (FURLS) Certificate Application Process (CAP). These take several weeks to process with no expedited review option. Some foreign governments require the additional step of verifying the export certificate via apostille or authentication from the U.S. Department of State or, in cases where the certificate was issued after April 2016, a unique Certificate ID, printed in the top left corner of every certificate, may be used to independently verify whether the export certificate was issued by FDA.

EAS offers U.S. import assistance as well as assistance for companies exporting product to foreign countries via the application of a certificate of export as well as obtaining apostille from the U.S. Department of State. Contact us for more information.

Fairman Discusses Tips to Ensure Compliance with Audits in Natural Products Insider

EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract manufacturer audits often have critical blind spots that may result in products not meeting specifications or their quality and safety expectations,” she says.

Couch Shares Dietary Supplement OLD Responsibilities in AgroFOOD Industry HI Tech

Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111, she says. “The development of critical OLD processes should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.”

Skolnik Discusses AERs in Natural Products Insider

Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act,” published in 2007 cover SAE reporting for manufacturers and OLDs as well as FDA notification to companies when FDA receives an SAE involving one of their products.

EAS to Exhibit, Present at SupplySide West in Las Vegas

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman, and President and COO Dean Cirotta will represent EAS at the upcoming SupplySide West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30-4:30 pm; and Tara and Heather will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30am-11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.

Cirotta to Moderate Panel at FDLI Conference Focusing on Tobacco and Nicotine Products

Dean Cirotta will moderate a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference concerning “The Latest on Product Standards and Other Potential Regulatory Action”. The conference, which takes place October 25-26, 2018 in Washington, D.C., will address issues of effectively regulating the broad spectrum of tobacco and nicotine products both in the U.S. and globally.

Planning for Emergencies – Document, React and Manage all Aspects When the Worst Happens

Dear Readers,

Welcome to the October 2018 edition of the EAS-e-News, a free news publication for industries regulated by FDA. I’d like to invite you to view our latest video discussing EAS services in the infant formula industry. These short videos are a few minutes in length and designed to give you a better understanding of EAS capabilities and expertise of our many talented consultants. You may find all of our capability videos at the bottom of the page under the food tab of the EAS website.

We have a number of new webinars planned for the month of October and early November that we invite you to sign up for. From Preparing for Tobacco TPMPs, to Own Label Distributor Responsibilities and Pharma Data Integrity our complimentary webinars offer the latest regulatory information in a concise one-hour format with time for Q&A.

Independent Consultant, Priya Jambhekar will be speaking at FDLI’s Introduction to Biologics and Biosimilars Law and Regulation on the Regulation of Biological Marketing. This event is being held October 3-4, 2018 in Washington, D.C.. Dean Cirotta will be moderating a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference which is also being held in Washington, D.C. on October 25-26, 2018. Independent Advisor for OTC Drugs and Labeling, Susan Crane, will be presenting a session as part of the CHPA Academy’s OTC 101 course on OTC drug labeling regulations. This course is being offered in Wilmington, DE October 9-10, 2018.

Our Issue of the Month article is written by Independent Consultant Norma Skolnik and is on the legislation to reform the OTC Drug Monograph System called the OTC Drug Safety, Innovation, and Reform Act. EAS has a strong team of consultants who have in-depth knowledge of the OTC monograph process as well as the Rx to OTC switch. Our FSMA Perspective written by EAS Independent Advisor for FSMA, Charles Breen is on FDA’s new fee-based program Export Certifications for certain food products.

We hope you enjoy this issue of EAS-e-News and we hope that you’ll join us at one of our many webinars and presentations in the coming weeks. It is always a pleasure to meet those who also have a vested interest in ensuring the safety and compliance of FDA Regulated products. We welcome your questions and comments and please feel free to share this newsletter with your colleagues.


Edward A. Steele

EAS Webinar Series Continues with Topics Ranging from Tobacco TPMPs, Own Label Distributors and Pharmaceutical Data Integrity

EAS is offering a number of complementary regulatory webinars this fall. Please join us for these live sessions or view one of our On-Demand webinars found under the Resources tab of our website.

Preparing for Tobacco TPMPs – October 9, 2018, at 1:00 pm Eastern

Join EAS President and COO, Dean Cirotta and Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. for a discussion of expectations for FDA’s in-development Tobacco TPMP Rule and how you can assess your current quality systems in preparation. This webinar is hosted in Cooperation with the Tobacco Merchants Association.

Own Label Distributor Responsibilities – October 11, 2018, at 1:00 pm Eastern

As more and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services, it is imperative that those in responsible positions for OLDs gain a full understanding of FDA’s requirements for knowing what and how these contracted activities are performed. Learn more about your “OLD” responsibilities and how to document that you are meeting them with EAS Independent Consultant, Bruce Elsner.

Problems with Pharma Data Integrity – October 18, 2018, at 1:00 pm Eastern

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years indicate that validation is a consistent problem. Join EAS Independent Consultant Brian Nadel to better understand the Agency’s expectations for data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.

Breen Co-Authors Article in Food Quality and Safety Magazine on Responding to Food Safety Emergencies

Independent Advisor for FSMA, Charles Breen has co-authored an article with Stacey Stevens, Senior Vice President of FoodMinds, a food PR firm with which EAS has a collaborative partnership on responding to a food safety emergency. The article, published in Food Quality and Safety magazine discusses the many issues of responding to an emergency and how to focus messaging on that response.

Legislation to Reform the OTC Drug Monograph System: The OTC Drug Safety, Innovation, and Reform Act

By Norma Skolnik, Independent Consultant

With the aim of overhauling the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey recently sponsored bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018, S.2315. The bill, which has already passed in the House of Representatives, was approved by the Senate Health, Education, Labor, and Pensions committee on April 24, 2018, and was received by the Senate at large on July 17, 2018. A previous bill, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, authored by Representative Bob Latta (R-OR) and others, was introduced over a year ago.

As most people know, the current monograph system, which was implemented in 1972, has received much criticism and there have been several prior efforts to revise what’s been called an outdated “broken system”. The current monograph system’s drawbacks include the slow rulemaking process (many OTC drugs are marketed under incomplete monographs), the inability to swiftly and promptly address safety issues, and barriers to innovation (eligibility is largely limited to active ingredients that were marketed before 1972). In addition, FDA has acknowledged that it currently lacks the resources to effectively regulate all OTC monograph products.

The proposed bill is intended to speed up the current slow and time-consuming regulatory procedures by introducing the administrative order process to replace the current rulemaking procedures. It provides options for manufacturers to request administrative orders and for FDA to initiate administrative orders on its own initiative as well as in response to a citizens’ petition.

The S2315 bill would also establish a process for the introduction of new OTC products that are marketed without an approved New Drug Application. This legislation would authorize the agency to grant 2 years of product differentiation and exclusive market protection for certain qualifying OTC drugs, thus delaying the entry of other versions of the same qualifying OTC product.

The bill also includes provisions that would provide FDA with the authority to take rapid action in the event of safety issues with OTC drugs and requires that FDA re-evaluate the OTC cold and cough monograph with respect to children under the age of six and report annually to Congress on the progress of this evaluation. This was prompted by a 2007 internal review that linked the deaths of 54 children younger than 6 years to the use of OTC decongestants and cough medications.

Additionally, the new legislation will help manufacturers who wish to develop innovative products, for example, by adding new ingredients or creating new dosage forms of existing OTC drugs. It should provide a more streamlined regulatory pathway for review of innovations within the OTC Monograph system, accommodating marketplace innovations, such as new uses for ingredients, dosage forms, and other advancements. It should also provide a mechanism to encourage investment in data needed for significant innovations.

Reforming the OTC monograph system should benefit consumers and give FDA the resources that it needs to provide effective oversight of these widely used drug products.

The proposed legislation updates the monograph process by specifically adding a new section to the Federal Food, Drug, and Cosmetic Act (FFD & C) to implement the following:

  • Move away from the cumbersome current monograph finalization process to an “administrative order” procedure. The system for future changes to Monographs would be through the administrative order procedure with an opportunity for development meetings or other consultations, comment on proposed orders, and dispute resolution protections
  • Include by reference existing OTC Review Final Monographs and deem final all existing Tentative Final Monographs by statute
  • Create new pathways to innovation for monograph products, where none currently exits
  • Ensure that the new drug approval pathway and other nonprescription drugs otherwise lawfully marketed are not affected
  • Create a mechanism for faster OTC drug safety label changes;

Importantly, the bill provides FDA with the authority to collect user fees to help cover much of the costs of updating the regulatory system and provide the necessary resources to evaluate and monitor the OTC drug market. It’s hoped that the user fees will provide FDA with the funding and staff required to better oversee OTC drug compliance and build a critical IT/electronic infrastructure. This bill differs from previous versions because of its’ exclusivity provision.

The OTC Drug Safety, Innovation, and Reform Act is now awaiting Senate action. There is a great deal of bipartisan support for this bill, including from the American Academy of Allergy, Asthma & Immunology, the American Dental Association, and the American Academy of Pediatrics, who have urged passage because of the need to overhaul and modify pediatric dosing for OTC drugs, particularly OTC cough and cold drugs. It’s also been supported by the Consumer Healthcare Products Association (CHPA), the leading U.S. trade association representing OTC drug manufacturers and marketers. However, although it has widespread support and appears likely to pass, this is not a “must pass” bill like other existing user fee legislation. When it does pass, this legislation will have an enormous impact on the OTC drug industry in this country.

Issue of the Month Author, Norma Skolnik

This month’s Issue of the Month on Serious Adverse Events Reporting is written by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting, she served as Director of Regulatory Affairs for the Americas for Cadbury Adams until her retirement. She also held the positions of Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

Drug and Device Corner 2018 September

EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period. The FDA has released several guidance documents to assist.

In the event you not already seen the Statement from FDA Commissioner Scott Gottlieb, M.D, EAS highly recommends you read this to understand the FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities. The statement includes a link to the FDA’s published internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections.

In addition, FDA recently announced a Special 510(k) Program Pilot, which aims to expand upon the types of changes eligible for the Special 510(k) Program to improve the efficiency of 510(k) review. FDA is working to simplify the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles. As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices.  EAS offer 510(k) review and submission assistance. Please contact us for more information.

Guidance Document updates on the FDA website:

All centers:

Postapproval Changes to Drug Substances

Civil Money Penalties Relating to the Data Bank


Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Allergic Rhinitis: Developing Drug Products for Treatment

Nonallergic Rhinitis: Developing Drug Products for Treatment

Physiologically Based Pharmacokinetic Analyses — Format and Content

Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications

FDA Product-Specific Guidances for Generic Drug Development webpage

FDA in Brief: FDA issues 54 product-specific guidances to promote generic drug access and drug price competition 


Hematologic Malignancy and Oncologic Disease: Considerations for User of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format


Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

Recognition and Withdrawal of Voluntary Consensus Standards

510(k) Third Party Review Program

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions