FDA Related News

Medical Devices

Consider DaVinci Cautery Instrument Ban: Petition

Unplug the Robot activist Jennifer Nelson asks FDA to consider banning and recalling all DaVinci Robot permanent cautery instruments.

Federal Register

Guide on Drug Packaging and Labeling Terms

Federal Register notice: FDA makes available a final guidance entitled Selection of the Appropriate Package Type Terms and Recommendations for Labelin...

Federal Register

Draft Guide on ANDA Blocking Petitions

Federal Register notice: FDA makes available a draft guidance entitled Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of...

Medical Devices

CDRH Plans 21 Guidances This Year

CDRH issues a list of 21 final and draft gudiances it expects to publish in FY 2019.

Glaxo Resuming Some Doctor Payments

GlaxoSmithKline reverses a 2013 policy and will pay some doctors for promoting some of its drugs.

Human Drugs

FDA Clears CarboFix Carbon Fiber Connectors

FDA clears a CarboFix in Orthopedics 510(k) for the CarboClear Carbon Fiber Transverse Connectors to be used in conjunction with its Carbon Fiber Pedi...

Human Drugs

Liveyon Recalls Stem Cell Product

Liveyon recalls all ReGen Series stem cells due to reported adverse reactions.

Federal Register

Guide on Atopic Dermatitis Pediatric Studies

Federal Register notice: FDA makes available a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs....

Human Drugs

Fast Track for VistaGen Non-opioid Pain Killer

FDA grants VistaGen Therapeutics a fast track designation for AV-101, a non-opioid, non-sedating treatment for neuropathic pain.