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REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period.

The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based Hand Sanitizers. With a thank you to all companies who entered into the market to supply hand sanitizer during the health emergency, the FDA notes there is now a sufficient supply available, and there is no longer a need to provide products that are not manufactured in compliance with the FDA OTC tentative final monograph. Production of EUA formula alcohol and / or hand sanitizers must cease as of 31 December 2021. The rule allows for sanitizers manufactured before this date to be sold or distributed up until 31 March 2022. After this date, only manufacturers / drug products compliant with the monograph and all other relevant manufacturing requirements will be allowed to market hand sanitizers. If you have questions on the status of your product, or your establishment registration and listings, please reach out to EAS.

Implementation of DMF form 3938 has begun. Form 3938 should be included with all DMF submissions. A blank copy and instructions can be downloaded from the DMF Submission Resources webpage. The document is quite straightforward, however, EAS is here for support should that be required.

The FDA announced on 20 September 2021 the Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs  enacted under the new process established by the CARES Act. The agency has created a web portal OTC Monographs@FDA where these orders will be posted. The system will also serve as a search tool for proposed and final administrative orders that add, remove, or change conditions for an OTC monograph.

One of the initial deemed final administrative orders announced was the Final Order for OTC Sunscreen Drug Products. Based on the fact that the final order is in line with the existing terms described in an FDA enforcement discretion policy, the agency believes most sunscreens currently on the market will be considered in compliance with the deemed final order. The agency also has a proposed order which would include changes to the deemed final order for certain requirements of active ingredients, labeling and effectiveness. More information and instructions for submitting comments can be found on the FDA website.

The FDA and the United Kingdom’s Veterinary Medicines Directorate (VMD) jointly announced a Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs. This expands on the 1 January 2021 MRA which focused on human pharmaceuticals. The addition of facilities / companies that manufacture animal drugs will help both agencies’ efficiency by eliminating duplicate inspection processes. Resources can then be focused on other areas where there may be greater risk. Full details are available on the website.

In the event you had not been aware, the FDA has drastically revamped their FDA Inspection search tool. The new website titled ‘FDA Data Dashboard’ has compiled the following search tools into one webpage: Inspections, Compliance Actions, Recalls, Imports Summary, Import Refusals and Imports Entry. Always industry supportive, the agency has provided a How to Use the Dashboard website for instructions.

The FDA recently announced a change in the process for Certificates of Pharmaceutical Product. Beginning 3 December 2021, the agency will be issuing electronic Certificates of Pharmaceutical Product (eCPP) and will no longer issue or mail paper CPPs. The downloadable .pdf of the eCPP will be available via a company’s CDER eCTAS system. The FDA will be adding a unique Quick Response (QR) code to the eCPP/export certificate. Applications received prior to the implementation date will be handled with the existing process and a physical certificate will be issued. If you have any questions on this anticipated change, please contact Victoria Pankovich at EAS for further details.

Guidance Documents of interest

Controlled Correspondence Related to Generic Drug Development Guidance for Industry

This guidance document replaces the September 2015 guidance regarding controlled correspondence related to generic drug development. The new guidance provides information on the process to submit a CC requesting information related to generic drug development, as well as the agency’s process for providing feedback to such requests.

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals

This Addendum is to be used in close conjunction with ICH S1A Guideline on the Need for Carcinogenicity Studies for Pharmaceuticals, S1B Testing for Carcinogenicity of Pharmaceuticals, and S1C(R2) Dose Selection for Carcinogenicity Studies. The Addendum is complementary to the S1 Guidelines.

Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS

As a Founding Regulatory Member of ICH, the FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance to industry.

Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry

This guidance consists of the previously published FDA guidances, Q2A and Q2B. It is the same, in substance, as those two guidances, and it is the same, in substance, as the November 2005 ICH Q2(R1) guideline.

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements which apply to both types of products.

Electronic Submission Template for Medical Device 510(k) Submissions

The FDA is issuing a draft guidance document for submitters of 510(k) files to CDRH and CBER. The intention is to offer guided submission preparation tools for industry with the objective of improved submission consistency and enhanced efficiency for the review process.

Acceptance Review for De Novo Classification Requests

This guidance provides recommendations with further detail regarding the types of information FDA believes are necessary to conduct a substantive review for a De Novo request, as well as recommendations regarding the acceptance review process.

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs

This guidance describes principles for designing, conducting, and reporting the results for investigations or studies, including data from foreign countries, in submissions to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug.

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

Federal Register notices

FR Vol 86, No. 190 Medical Device De Novo Classification Process

FDA websites of interest

Q&A for Industry | Withdrawal of Temporary Hand Sanitizer Guidances

Patent Certifications and Suitability Petitions

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