FDA Related News

Medical Devices

FDA Issues Least Burdensome Guidance

FDA publishes a draft guidance explaining its view of Congress requirement that it apply least burdensome principles to medical device review.

High Throughput Sequencing Can be Standardized: FDA Research

FDA scientists say it is possible to standardize high throughput sequencing to screen biologics for contamination.

Federal Register

Comments on PDMA Information Collection Extension

Federal Register notice: FDA seeks comments on an information collection extension for Prescription Drug Marketing Act of 1987 Administrative Procedu...

Federal Register

Comments Sought on GMP Info Collection Extension

Federal Register notice: FDA seeks comments on an information collection extension for Current Good Manufacturing Practice Regulations for Finished Ph...

Federal Register

Workshop on Patient-focused Drug Development

Federal Register notice: FDA announces a 3/19/18 public workshop entitled Patient-Focused Drug Development: Developing and Submitting Proposed Draft G...

Human Drugs

Appeals Court Rules Against Amgen in Neupogen Biosimilar Case

The Federal Circuit Court of Appeals rules against Amgen in the continuing dispute between it and Sandoz over application of provisions of the Biologi...

Medical Devices

FDA Still Against Using Morcellators for Most Fibroids

An updated FDA assessment says the agency continues to caution against using laparoscopic power morcellators to treat presumed uterine fibroids.

Human Drugs

2014 Baxter FDA-483 Released

FDA releases the FDA-483 issued after a 2014 inspection at Baxter Healthcare.

Medical Devices

Chemence Medicals Exofin Fusion Skin Closure Device Cleared

FDA clears a Chemence Medical 510(k) to market and sell Exofin Fusion, a new skin closure system for medium to large wounds.

FDA General

FDA Wants More Consumer Information Available

HHS lists drug and medical device regulatory priorities for FDA.