Drug and Device May 2023 - EAS Consulting Group

As we approach June, keep in mind that drug establishment registrations and NDC listings that have had any changes to their information must update their files with the FDA within 30 days. Failing that, the agency expects updates to be submitted the JUNE or December following such a change. Do make sure your registration and listing information is up to date. If you need any assistance with the process, please reach out to EAS. (vpankovich@easconsultinggroup.com / usagent@easconsultinggroup.com)

Reminder that OTC drug monograph 2023 OMUFA facility user fees are due 1 June 2023. If you have questions on this program or need assistance, please contact Victoria Pankovich.

The FDA has posted five administrative orders as deemed by the CARES Act on the OTC MONOGRAPHS @ FDA website. This is a good website to periodically review for changes / updates.

Highlighted Guidance Documents

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. This guidance is also intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. FDA is identifying October 1, 2023 as the date on which we will require that 510(k) electronic submissions be provided. FDA intends to accept 510(k) submissions saved to a form of electronic storage media and mailed to FDA if they are received by FDA before October 1, 2023.

Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol

This guidance is intended to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG). FDA has received and continues to receive (most recently in early 2023) reports about fatal poisonings of consumers who ingested drug products in a liquid dosage form (such as cough, allergy, analgesic, and antiemetic drug products) that were manufactured with DEG- or EG-contaminated components.

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.” The document provides guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same title issued on February 22, 2019.

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022

This guidance provides information to stakeholders regarding EFDA’s implementation of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) under Title I of The FDA User Fee Reauthorization Act of 2022. Because PDUFA VII created changes to the user fee program, this guidance explains the changes created by the statute which includes changes to certain definitions, changes to certain PDUFA fee exceptions, waivers, exemptions, reductions, and returns2 and certain changes for PDUFA invoicing procedures.

Decentralized Clinical Trials for Drugs, Biological Products, and Devices

This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. In fully decentralized clinical trials, all activities take place at locations other than traditional trial sites. These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants. In hybrid DCTs, some trial activities involve in-person visits by trial participants to traditional clinical trial sites, and other activities are conducted at locations other than traditional clinical trial sites, such as participants’ homes.

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