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As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops.

EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent Advisor OTC Drugs and Labeling. We thank Susan for her outstanding support of EAS clients and our staff over the years and wish her much happiness in her retirement.

Beginning 30 September 2022, please send any requests for service to Victoria Pankovich, Manager, Regulatory Services at vpankovich@easconsultinggroup.com. If you have questions, please do not hesitate to reach out to either Victoria, or Ms. Lisa El-Shall, Sr. Director Pharmaceutical & Medical Device Consulting Services, lelshall@easconsultinggroup.com.

Susan will be missed, but be assured, EAS is available to continue to provide you with the same expert services to which you are accustomed.

Reminder that the establishment registration and product listing renewal period for both drugs and devices begins 1 October 2022. Kindly note for drug products that the FDA has tightened up their validation process for listings. Although repack / relabeled listings have been submitted in the past without source NDC identification, this is no longer possible. Source NDCs must be included with all repack / relabel NDC listings. Also note, the FDA is now verifying business processes of all identified establishments in NDC listings. This could potentially slow down certification or updating of an NDC listing if the proper business process is not identified in a registration. Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle your registration renewal and / or your NDC listing required updates or certification.

As we approach the renewal period and end of the calendar year, please do remember that the CARES Act requires reporting the amount of listed drugs and biological products to the FDA. This includes most drugs for which an NDC number is assigned and submitted to the agency. (there are a few exemptions noted in the draft guidance) Although the deadlines indicated in the Reporting Amount of Listed Drugs and Biological Products draft guidance are only guidelines, the reporting is still mandatory for FY2020 and FY2021. Contact EAS is you require assistance with this process. 

The FDA released an immediately in effect guidance document Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency to describe where these exemptions and exclusions are applicable. The agency very clearly states this guidance document does not address the prescription-only status of FDA approved naloxone products.

Guidance Documents of Interest

Charging for Investigational Drugs Under an IND: Questions and Answers

This guidance provides information for industry, researchers, physicians, institutional review boards, and patients about the implementation of FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009.

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers

This Q&A document is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs (October 2005) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005). This guidance revises ICH E14 Q&As Q12 (5.1) and Q13 (6.1), and adds new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance finalizes the draft guidance issued in September 2020.

Electronic Submission Template for Medical Device 510(k) Submissions

This guidance provides the further standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement.

Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products

This guidance provides recommendations for quantitative labeling of sodium, potassium, and phosphorus present in human prescription and nonprescription (commonly referred to as OTC) drugs. This guidance addresses sodium, potassium, and phosphorus when present as constituents of active or inactive drug ingredients. Products within the scope of this guidance’s recommendations are orally ingested products and injectable medications containing an amount of 5 mg or more of sodium, potassium, or elemental phosphorus per maximum single dose.

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products

This draft guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This draft guidance also provides recommendations on the inclusion of the drug product’s strength on the labeling. The recommendations in this draft guidance are intended to help manufacturers, packers, distributors, applicants, relabelers, and sponsors ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products.

Q3D(R2) – Guideline for Elemental Impurities

ICH Draft Guidance for Industry, this guidance presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in the ICH guidance for industry Q9 Quality Risk Management (June 2006) (ICH Q9). This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.

Computer Software Assurance for Production and Quality System Software

FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. This draft guidance is intended to 1) Describe “computer software assurance” as a risk- based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate; and 2) Describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820.

All Guidance Documents can be searched on the FDA’s website.

Federal Register

FR Vol 87, No 178 Presidential Documents Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy

FR Vol 87, No 176 Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act


Study Data Standards Update for CBER: Your Guide to a Successful Submission

Date: October 5, 2022
Time: 1:00 PM – 2:00 PM ET

An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Date: October 26, 2022
Time: 1:00 PM – 4:00 PM ET

Best Practices for Utilizing Modeling Approaches to Support Generic Product Development

Date: October 27 – 28, 2022
Day 1: Thu, Oct 27 8:30 AM – 5:00 PM ET
Day 2: Fri, Oct 28 8:30 AM – 3:40 PM ET

Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development

Date: November 3, 2022
Time: 8:30 a.m. – 5:00 p.m.

FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement

Date: November 14 – 16, 2022
Day 1: Mon, Nov 14 10:00 AM – 3:00 PM ET
Day 2: Tue, Nov 15 10:00 AM – 3:00 PM ET
Day 3: Wed, Nov 16 10:00 AM – 4:00 PM ET

Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned Webinar

Date: December 6, 2022
Time: 8:30 AM – 5:00 PM ET

Posted in Drug and Device Corner, Drugs, Medical Devices.