Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain, (i.e., mandatory and optional ingredients. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit(TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard.

About the Presenter

April Kates was most recently a supervisory consumer safety officer at FDA. Prior to that position, she served with USDA’s Food Safety and Inspection Service Federal-State Audit Branch, also as a supervisory consumer safety officer. Previously, she served as manager of regulatory compliance at McCormick Spice Company, as a food regulatory specialist at American Ingredients Company (now Corbion), as a program analyst at FSIS, and as a food technologist at FDA.

Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks.

About the Presenter

Peter Saxon has extensive experience in assisting pharmaceutical companies to prepare for FDA inspections of API and finished dosage plants for the U.S. market. He brings 45 years of experience in technical operations, materials management, and business development background in the pharmaceutical industry. His expertise includes pre-inspection audits, Drug Master File (DMF) preparation, equipment, cleaning, computer and process validations as well as QA training. A consultant since 1993, he has assisted major US pharmaceutical companies through FDA consent decrees and guided foreign API and finished dosage manufacturers through FDA inspections. Prior to consulting Saxon served in management roles with Ciba-Geigy Corporation, including stints in Cairo, Egypt, and Basel, Switzerland. Mr. Saxon holds an MBA from Rutgers University, and a BS in chemical engineering from Manhattan College, Riverdale, NY. He is fluent in German and has a working knowledge of Spanish, French, Arabic, and Chinese

Sean T. Wall

Just wanted to say thank you for the information shared at the Dietary Supplement GMP training last week. I’ve been to many trainings/seminars over the years, many of which I left thinking “WOW…I’m never going to use what I just learned.” I’m pleased to say that after leaving this training, I felt confident that I’d be immediately using at least 90% of the information that I learned. There are several follow-ups that I have planned here, some of which were points that I’m not sure we were aware of, and others that will only strengthen some of our current programs. The training was informative and very well delivered. The Q&A allowed throughout was also informative, yet never veered too far off course. As a previous trainer, I understand how important good interaction can be, but I also understand how quickly a conversation can go off on a tangent. You had a great mix of letting things happen, yet kept it corralled. Great job!

Hanna S.

Thanks for delivering a jam-packed learning experience. It was so well done and very important work. I’m feeling ready to roll up my sleeves!

Cheryl Ensign

I consider myself a seasoned professional in regulatory compliance for the food/supplement industry. The instructors were very personal and information was presented with lots of practical experiences and details. Powerful take aways! Never too experienced to learn a whole lot more!

Jessica Wurtz

I wanted to write a quick note and say that I thoroughly enjoyed the training class. It was extremely thorough, packed with useful information, and was presented very well. Thank you very much for sharing both of your experiences as well; they definitely added significant value because of the real-world applications for the information. I was really excited to share it with my management team!

Kimberly Vance

You [Bob Fish] and the other instructors did a great job with the course! I learned a lot. I feel like a new person, and am now more equipped to audit my contract manufacturers against the standard. Thanks for answering all of my questions and giving your insight on industry findings.

Brittini Gehring, MH, Chief Botanical Officer

The program was extremely comprehensive. The course materials were structured and detailed. It broke down 21 CFR Part 111 into very easy to comprehend sections that allowed me to simultaneously create a list of immediate actions to apply at our facility to help us become even more GMP compliant! The course helped me to understand how to tie up a lot of previously confusing loose ends. Thank you to all the instructors and to EAS for providing the course!

Sydnie Boral

I am very impressed with the quality of this presentation and the presenters. I am new to cGMP and this has been a most valuable overview.

Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations

Presented by:
Tara Lin Couch, Ph.D.
Senior Director, Dietary Supplement and Tobacco Services

As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the Cannabis industry to begin assessing your manufacturing processes and implementing sound and effective quality systems in order to help you begin to prepare for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry.

About the instructor

Tara Lin Couch, PhD
Senior Director, Dietary Supplement and Tobacco 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.

Drug and Device Corner 2018 July

EAS would like to bring to your attention the Draft Guidance released by the FDA for ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA. This guidance describes the significant difference between GDUFA I and GDUFA II Amendments and the timelines associated with their review. The FDA considers all submissions to an ANDA to be an amendment, they will be classified based on the content and issued a goal date consistent with that classification. Please review the guidance for further details.

In the FDA’s ongoing effort to make generic affordable drugs available to the public, they have published product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs. These guidances are hoped to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating the evidence needed to support ANDA approval. Please see the FDA’s Product-Specific Guidances for Generic Drug Development webpage for more details.

The FDA issued a press release regarding its recent actions on bulk drug substances used for compounding. Their Bulk Drug Substances Nominated for Use in Compounding lists for 503A Category drugs and 503B Category drugs have been updated as of 23 July 2018. Included in the update are the changes to the lists and when the changes became effective. Please see the press release for full details. 

The Food and Drug Administration (FDA) announced a public hearing to solicit input from the public on how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation. The hearing will be held on Tuesday 4 September 2018, from 9 a.m. to 5 p.m. at the Food and Drug Administration’s White Oak Conference Center. If you would like to participate and weigh in on this hearing, more information on how to register for the meeting or the live webcast can be found in the Federal Register Notice.

Guidance Document updates on the FDA website

All centers

Use of Electronic Health Record Data in Clinical Investigations

CDER

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention

Q3D(R1) Elemental Impurities

Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs

Innovative Approaches for Nonprescription Drug Products

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

Use of Liquids and / or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

CDER & CBER

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017

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

E17 General Principles for Planning and Design of Multiregional Clinical Trials

Field Alert Report Submission Q & A

Labeling for Biosimilar Products

Inborn Errors of Metabolism That use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

E17 General Principles for Planning and Design of Multiregional Clinical Trials

CDRH

Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions

CBER

Human Gene Therapy for Retinal Disorders

Long-Term Follow-Up After Administration of Human Gene Therapy Products

Human Gene Therapy for Rare Diseases

Chemistry, Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

Human Gene Therapy for Hemophilia

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

CVM

Antimicrobial Animal Drug Sales and Distribution Reporting

#257 Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species

Getting Your Medical Device Into the U.S. Market

If you are a manufacturer whose medical device is either a Class I, or a 510(k) exempt device Class II device, consider yourself and your company lucky that you do not have to try to “thread the needle” of the litigious and arduous process known as 510(k) clearance. Getting a device ready for 510(k) submission is usually time-consuming, costly, and full of challenges.

All 510(k)’s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. If you are the maker of a Class II medical device or an IVD and want to launch it in the U.S. market, you must submit a 510(k) to the FDA. For Class III devices, a premarket approval (PMA) submission is needed.

510(k)’s have unique content and format requirements – they are not identical to a European Technical File – and the FDA’s recent changes to 510(k) requirements make the submission process more rigid than ever.

Class II devices are designed to perform as indicated without harming patients or users, but they require a greater level of safety and effectiveness assurance than do Class I devices. Examples include powered wheelchairs, infusion pumps, surgical drapes, surgical needles, suture material, and acupuncture needles.

Class III medical devices do not have enough information to ensure safety and effectiveness through the general or special controls used for Class I or Class II devices. These higher-risk devices need premarket approval (PMA), which includes a scientific review, to ensure their safety and effectiveness. Examples include replacement heart valves, silicone gel-filled breast implants, and implanted cerebral stimulators.

Here are some practical tips for a 510(k) filing:

  • Establish a “Regulatory plan” as early in the process as possible. The regulatory plan should include a list of all the deliverables required. The plan needs to be owned by all the applicable team members not just the person issuing the plan.
  • Don’t be surprised or disheartened that questions will arise despite your best efforts. The FDA is swamped with 510(k) reviews and any deficiency that they can find in your submission allows them to go to the next submission to keep the commitment that the FDA will review all submissions in a timely manner. “Put yourself in the FDA examiner’s shoes”.
  • Don’t try to blind the FDA examiner with excessive or extraneous information in the hope that they will bypass the information for the sake of time. In my experience, the FDA examiners read every document and every page!

The FDA sends back most 510(k)’s during the first review cycle to request more information – in recent years this has applied to more than 70% of 510(k) submissions!

Also, many medical device companies are compiling and submitting 510(k)’s to the FDA for review without establishing a Quality Management System and without documenting Design Controls and without documenting Risk Management which can bode trouble for the submission as well as FDA inspection time.

You might want to consider using a competent consultant or at least asking an objective party to review the submission for completeness before sending it to the FDA. This will minimize the risk of delay and rejections.