Devices

Least Burdensome Guidance Outlined

A 3/14 CDRH Webinar discussed the 2/5 final guidance on concepts and principles of the “least burdensome” regulatory information provisions. CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein said the guidance describes the agency’s use of the least burdensome approach through medical device regulation to remove or reduce unnecessary burdens that could delay marketing of beneficial products while maintaining the legal requirements for clearance and approval.

He reported that 79 comments were received on the draft guidance from 13 external stakeholders. Most of the comments supported the proposal, he said, and there were revisions and additional requests on the least burdensome definition and guiding principles.

The seven least burdensome guiding principles identified by Silverstein from the guidance are:

FDA intends to request the minimum information necessary to adequately address the regulatory question or issue at hand;
industry should submit material including pre-market submissions to FDA that are least burdensome for FDA to review;
FDA intends to use the most efficient means to resolve regulatory questions and issues;
the right information should be provided at the right time;
regulatory approaches should be designed to fit the technology, considering its unique innovation cycles, evidence generation needs, and timely patient access;
FDA intends to leverage data from other countries and decisions by or on behalf of other national medical device regulatory authorities to the extent appropriate and feasible; and
FDA intends to apply least burdensome principles in international medical device convergence and harmonization efforts.

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