FDA Policy/General

Latest Federal Register Notices

Guide on Bench Testing Data in Device Submissions
Federal Register notice: FDA makes available a final guidance entitled “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.” 04/26/2019

Guide on Polyethylene Used in Devices
Federal Register notice: FDA makes available a final guidance entitled “Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.” 04/26/2019

Info Collection Extension on Device Small Biz Fee
Federal Register notice: FDA submits to OMB an information collection extension entitled “Medical Device User Fee Small Business Qualification and Certification.” 04/26/2019

Info Collection Extension on Device Sterilization Agreements
Federal Register notice: FDA seeks comments on an information collection extension for its “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150.” 04/26/2019

Final Guide on UDI Convenience Kit Labeling
Federal Register notice: FDA makes available a final guidance on “Unique Device Identification: Convenience Kits.” 04/26/2019

Covariates in Randomized Clinical Trials Guide
Federal Register notice: FDA makes available a draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” 04/25/2019

Draft Guide on Initiating Voluntary Recalls
Federal Register notice: FDA makes available a draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” 04/24/2019

Panel to Discuss Surgical Staplers & Hemostatic Agents
Federal Register notice: FDA announces a 5/30-31 Advisory Committee meeting to discuss reclassification proposals for surgical stapler devices and certain absorbable hemostatic agents. 04/24/2019

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,

Read more

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