FDA Policy/General

Information Collections Approved by OMB

Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are:

Experimental Study of an Accelerated Approval Disclosure
Interstate Shellfish Dealer’s Certificate
Administrative Detention and Banned Medical Devices
Medical Device User Fee Small Business Qualifications and Certifications
Individual Patient Expanded Access Applications
Electronic Forma for Submissions; Promotional labeling and Advertising Materials for Human Prescription Drugs
Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Electronic Submission of Medical Device Registration and Listing
Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

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Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes