Devices

Device Breakthrough Designation May be Made Public: Shuren

CDRH director Jeffrey Shuren has told The MedTech Conference in Boston that FDA may be willing to make public which devices are awarded breakthrough designation. He also said he predicts that the number of breakthrough devices getting final marketing approval will spike in about a year.

MedTechDive reports online that historically FDA has not made the designations public but, according to Shuren, “it would be worthwhile to hear more from companies as to the comfort level on doing that. We have tried to be respectful that we do, in fact, have a number of companies who do not want it to be public yet, just from a competitive standpoint. And so we have not put out a list or anything that’s in the public domain if it hasn’t been said by the companies.”

Shuren said that so far 12 devices have received a breakthrough designation.

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