FDA Related News

Human Drugs

Report on Alopecia Patient Perspectives for Drug Development

FDA releases a report entitled The Voice of the Patient: Alopecia Areata that summarizes a 9/2017 public meeting that heard from patients and caregive...

Federal Register

FDA Joint Panel to Review InfaCare Pharma NDA

Federal Register notice: FDA announces a 5/3 joint Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee meeting.

Human Drugs

Plaintiffs Need to Prove Newly Acquired Evidence: Attorney

Attorney Steven Boranian says courts are requiring plaintiffs to provide specific facts detailing what drug companies knew about a new risk and when t...

Human Drugs

FDA Denies Mayne Pharma Doryx MPC Petition

FDA denies a Mayne Pharma petition asking it to mandate specific dissolution criteria as part of demonstrating bioequivalence of generic forms of Mayn...

Biologics

Gottlieb: FDA Working on a Dozen New Biosimilar Policies

FDA commissioner Scott Gottlieb says the agency is working on about a dozen new policies to help the fledgling biosimilar market grow and gain accepta...

Human Drugs

USP Proposal on Biologicals Concerns FDA

FDA says a proposed USP monograph on biological products should be withdrawn because it could impede or delay licensure of biosimilars.

FDA Issues FDARA Inspection Report

FDA publishes statistics relating to drug and medical device facility inspections required under the FDA Reauthorization Act.

Human Drugs

Info Collection Extension for New Dietary Ingredients

Federal Register notice: FDA submits for OMB approval an information collection extension for Premarket Notification for a New Dietary Ingredient 21 ...

Human Drugs

FDA Consent Decree with MyNicNaxs

A federal judge approves a consent decree of permanent injunction sought by FDA against dietary supplement distributor MyNicNaxs and two of its execut...

Medical Devices

Sponsors Must Self-Identify Combination Products: FDA

CDRH Office of Device Evaluation policy analyst James Bertram tells a Webinar audience that changes under the Cures Act require sponsors to self-ident...