FDA Related News

Yates Memo Accountability Eased

Attorney Anne Walsh outlines Justice Department changes to the Yates memo on individual accountability in criminal and civil cases, including those in...

Human Drugs

FTC Supports FDA Deterring Petition Abuse

The Federal Trade Commission says it shares FDA concerns about abuse of the citizen petition process to delay approval of generic drugs and will work ...

Human Drugs

6 Observations in Gadea Biopharma FDA-483

FDA releases an FDA-483 with six observations from an inspection at Spains Gadea Biopharma.

Federal Register

Info Collection Extension for Drug Supply Chain Guide

Federal Register notice: FDA has submitted to OMB an information collection extension entitled Guidance for Industry: Drug Supply Chain Security Act I...

Federal Register

InSightecs Exablate Regulatory Review Period Determined

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for InSightecs medical device Exablate.

Federal Register

Info Collection Extension on Device e-Registration & Listing

Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic Submission of Medical Device Registration and L...

Medical Devices

FDA Approves Olympus Device for Emphysema

FDA approves Olympus Spiration Valve System for treating severe emphysema, a progressive form of chronic obstructive pulmonary disease.

Human Drugs

Improvements to FDA Adaptive Design Guidance Praised

PHRMA praises FDA for its new draft guidance on adaptive designs for clinical trials of drugs and biologics.

Medical Devices

FDA Clears Subtle Medical AI Technology for Images

FDA clears a Subtle Medical 510(k) for the SubtlePET, an artificial intelligence-powered technology that the company says allows hospitals and imaging...

Medical Devices

FDA Clears Bausch & Lomb Astigmatism Contact Lens

FDA clears a Bausch & Lomb 510(k) for its Ultra Multifocal for Astigmatism contact lens, a monthly silicone hydrogel lens.