FDA Related News

Medical Devices

Intuitive Surgical 510(k) for Robotic Lung Biopsy

Intuitive Surgical files a 510(k) for the companys new flexible robotic-assisted, catheter-based platform for lung airway biopsies.

Human Drugs

FDA Making Progress in Generic and Biosimilar Access: Abram

FDA deputy commissioner Anna Abram says the agency is making significant progress on action plans to improve drug competition and access to biosimilar...

Federal Register

Comments Extended for Gene Therapy Guidances

Federal Register notice: FDA extends the comment period on six draft guidance documents about developing human gene therapy products.

Federal Register

Guide on Uncertainty in Device Benefit-Risk Determinations

Federal Register notice: FDA makes available a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical D...

Medical Devices

AMDT Holdings 510(k) for Deformity Analyzer

FDA clears an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation.

Human Drugs

Beaumont Bio Recalls Contaminated Product Line

Beaumont Bio Med recalls its entire aqueous/alcohol-based product line due to possible microbial contamination.

Medical Devices

Draft Device Uncertainty Determination Guidance

FDA issues a draft guidance describing its approach to considering uncertainty in making benefit/risk decisions for some medical device applications.

Human Drugs

Allergic, Nonallergic Rhinitis Guidances Out

FDA publishes guidances to assist sponsors in developing drugs to treat allergic rhinitis and nonallergic rhinitis.

Human Drugs

CDER Inspection Site Selection Model MAPP

CDER issues a MAPP on policies and procedures for the site selection model used by the Office of Surveillance to prioritize manufacturing sites for ro...

PhRMA Analysis Finds Hospitals Jacking Up Drug Prices

A new analysis commissioned by PhRMA shows that about one in five hospitals marks up medicine prices 700% or more.