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Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be updated and submitted to reactivate the listing. If you need assistance with the process, or would like EAS to handle this for you, please contact Victoria Pankovich.

FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December 2023. This draft guidance describes how the FDA will request and conduct voluntary remote interactive evaluations of drug facilities.

The guidance describes the various remote interactive tools the agency has developed. Any combination of these tools will be considered a ‘remote interactive evaluation’. This policy applies to all drug inspection programs, but use of an RIE will be solely at the discretion of the agency. Companies may not request an RIE. There are numerous factors that must be weighed by the agency in determining if an RIE would be appropriate for the given evaluation.

The FDA will contact any facility it identifies as a candidate for an RIE and request the facility’s cooperation. If the facility agrees to be evaluated remotely, the agency will schedule a brief virtual planning meeting. Full details can be found in the draft guidance.

In reviewing the FDA’s Warning Letter website, we’ve noticed an uptick in citing for CGMP/Finished Pharmaceuticals/Adulterated violations. EAS can perform a site audit and let you know if your facility needs improvements to comply with the GMP regulations. Our consultants can then assist you through the process of implementing the recommendations. Please contact us for further information.

The FDA announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information. Per the Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing Guidance Document, the agency will begin enforcement 1 July 2024. This new enforcement date applies to all facilities engaged in cosmetic product manufacturing and processing regardless of when they began operations. Included in the guidance document is the anticipated release date of submission tools (both electronic and paper) in ‘early December 2023’.

Please note that the regulation has not changed. EAS recommends that all cosmetic facilities should be working toward submission of registration information by 29 December 2023 if possible. Similarly, responsible persons should also be preparing product listing information for submission to the agency by 29 December 2023 if possible.

FDA Publishes Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings

Highlighted Guidance Documents

Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing

This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance document discusses FDA’s compliance policy for these requirements. FDA intends to delay enforcement of these requirements for six months to help ensure that industry has sufficient time to submit facility registration and product listing information.

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act

This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical devices that will help prevent or mitigate shortages of such devices. This guidance also recommends that manufacturers voluntarily provide additional information to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a PHE.

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19. This guidance describes FDA’s current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations. This guidance supersedes the guidance of the same name initially issued on May 19, 2020, and reissued on February 22, 2021.

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

This guidance document provides the FDA’s recommendations on a risk-informed framework for credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. This guidance applies to physics-based, mechanistic, or other first principles-based models. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions.

Enforcement Policy for Clinical Electronic Thermometers

FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for clinical electronic thermometers at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.


Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers 

Comments may be submitted to FDA-2008-D-0053 by 24 December 2023

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

Federal Register

FR Vol 88, No. 223 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format

FR Vol. 88, No. 203 Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024

FR Vol. 88, No. 203 Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024


FDA Clinical Investigator Training Course (CITC) 2023

Date: December 6 – 7, 2023
Day1: Wed, Dec 6 11:00 AM – 4:30 PM ET
Day2: Thu, Dec 7 11:00 AM – 4:00 PM ET

Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources

Date: December 12 – 13, 2023
Day1: Tue, Dec 12 12:00 PM – 2:00 PM ET
Day2: Wed, Dec 13 1:00 PM – 3:00 PM ET

Webinar – Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance

Date: January 11, 2024
Time: 1:00 PM – 2:00 PM ET

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