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We wish you all a very happy holiday season and prosperous new year.

Reminder of the deadline of 31 December 2022 for the establishment registration and product listing renewal period.

For those that have not already submitted their CARES Act reporting for FY2020 and FY2021, do note per the regulation these reports are due. Although the FDA proposed dates for submission of these reports were non-binding, the reports themselves are indeed required. If you need assistance with the process, please contact EAS for support. Do be thinking ahead for your FY2022 reporting.

Guidance Documents of Interest

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

This guidance replaces the November 2017 draft guidance for industry on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry

This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that FDA may take if the applicant fails to respond to that CRL.

Controlled Correspondence Related to Generic Drug Development

This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.

Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry

This guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. As discussed below, FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.

Statistical Approaches to Establishing Bioequivalence

This guidance provides recommendations on how to meet provisions of part 320 for all drug products.

Content of Human Factors Information in Medical Device Marketing Submissions

This draft guidance document provides the FDA’s recommendations on the human factors information that should be documented and included in medical device marketing submissions, when such are required.

CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern

This document provides guidance for industry to evaluate potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.

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

Federal Register

Federal Register Vol 87, No 236 Investigational New Drug Application Annual Reporting

Federal Register Vol 87, No 234 Homeopathic Drug Products; Guidance for Food and Drug Administration Staff and Industry; Availability


Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
Date: January 13, 2023
Time: 11:00 AM – 12:00 PM ET

FDA’s Labeling Resources for Human Prescription Drugs
Date: January 26, 2023
Time: 1:00 PM – 2:00 PM ET

Public meeting: FDA Rare Disease Day 2023
Date: February 27, 2023
Time: 9:00 AM – 4:45 PM ET

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