FDA Related News

Medical Devices

FDA Posts eMDR Enhancements

FDA lists enhancements to the CDRH electronic medical device reporting system and sets a schedule for future changes.

Federal Register

Patient-focused Drug Guide Docket Correction

Federal Register notice: FDA corrects the docket number associated with a 6/30 notice on a draft guidance entitled Patient-Focused Drug Development: S...

Human Drugs

Genetic Evidence Supports Many FDA Drug Approvals: Study

UK researchers say genetic evidence supports two-thirds of drugs FDA approved in 2021.

Federal Register

Federal Register Notices Week of July 4

FDA Webview posts the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holiday break.

Bill Introduced to Ban Misleading DTC Ads

U.S. Rep. Abigail Spanberger (D-VA) introduces the Banning Misleading Drug Ads Act that is intended to prevent manufacturers from obscuring dangerous ...

Human Drugs

HRA Pharma Files for OTC Birth Control Pill

HRA Pharma files an NDA for an Rx-to-OTC switch for the companys Opill (norgestrel .075 mg), a progestin-only daily birth control pill.

Human Drugs

Former FDA Generics Official Joins Lachman Consultants

After a 22-year career at FDA, CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shimer II joins Lachman...

Human Drugs

Hemophilia Group Wants REMS for 2 Investigational Gene Drugs

The National Hemophilia Foundation says FDA should require a REMS for two investigational gene therapies being reviewed as hemophilia treatments with ...

Medical Devices

LiveMetric 510(k) for Wrist Nano Sensor BP Monitor

FDA clears a LiveMetric 510(k) for its LiveOne, a wrist-worn nano-sensor technology for monitoring blood pressure every 10 seconds.

Federal Register

Regulatory Review Period for Imcivree

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rhythm Pharmaceuticals Imcivree (setmelanotide ...