FDA Related News

Create One PPI Guidance for all Products: Novartis

Novartis urges FDA to broaden its proposal on patient preference information beyond medical devices.

Human Drugs

Assessing GDUFA User Fees Guidance

FDA publishes a guidance with specifics about changes to user fees imposed under the GDUFA 3 reauthorization in 2022.

Human Drugs

FDA OKs Novaliq Dry Eye Drug

FDA approves a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease.

Human Drugs

FDA Ups Pediatric Exclusivity Requirements: Attorneys

Two SheppardMullin attorneys describe how two recent FDA guidances on pediatric drug development will tighten eligibility for pediatric exclusivity.

Human Drugs

FibroGens Pamrevlumab Fails Phase 3

FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.

Medical Devices

AdvaMed Recommendations for Patient Preference

AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...

Medical Devices

Teleflex Pacing Guidewire Cleared

FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire a bipolar temporary device designed specifically for use during transcatheter...

Federal Register

ICH Guide on Good Clinical Practice

Federal Register notice: FDA makes available a draft guidance entitled E6(R3) Guideline for Good Clinical Practice.

Federal Register

Braun EUA Revoked on Propofol-Lipuro

Federal Register notice: FDA revokes an emergency use authorization issued to B. Braun Melsungen AG for propofol-lipuro 1% injectable emulsion.

Biologics

CBER Post-Covid Transition Information

CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emergency.