FDA Related News

Medical Devices

Guidance on IDE Benefit-Risk Determinations

FDA releases a final guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.

FDA General

Trump Talks to 2 Silicon Valley Execs About FDA Roles

President-elect Donald Trump 1/12 meets with two Silicon Valley associates of billionaire tech investor Peter Thiel for potential posts at FDA.

Federal Register

Influenza Virus Antigen Detection Tests Reclassified

Federal Register Final Order: FDA reclassifies antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus d...

Federal Register

Vaccine Advisory Committee to Review Influenza Vaccines

Federal Register Notice: FDA announces a 3/9 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations o...

Federal Register

Panel to Review Peroxide-based Contact Lens Products

Federal Register Notice: FDA announces a 3/17 joint Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advi...

Federal Register

Joint Panel to Review Opana ER Safety Concerns

Federal Register Notice: FDA announces a 3/13 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic...

Federal Register

Guide on OTC Products Containing Acetaminophen

Federal Register Notice: FDA makes available a guidance entitled Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and L...

Human Drugs

Infectious Disease Designation for RedHill Therapy

FDA grants RedHill Biopharma a Qualified Infectious Disease Product designation for RHB-104 and its use in treating Nontuberculous Mycobacteria infect...

FDA General

FDA, IBM Open Health Data Exchange Project

FDA and IBM Watson Health sign a two-year agreement to research the exchange of healthcare data supported by blockchain technology.

Industry May Prefer to Keep Intended Use Rule

Two Mintz Levin attorneys say that drug and medical device companies should consider urging Congress not to roll back an FDA final rule changing the d...