FDA Related News

Medical Devices

Law Extends Product Info Sharing Safe Harbor to Devices

The recent omnibus legislation extends a drug company safe harbor to medical device companies on sharing health care economic information, according t...

Biologics

Evusheld May Not Neutralize New Covid Variant: FDA

An FDA update says AstraZenecas Evusheld may not neutralize the new Covid-19 variant XBB.1.5.

Human Drugs

FDA Delays Toripalimab PDUFA Action Date

FDA delays the PDUFA action date for Junshi Biosciences toripalimab because Covid travel restrictions involving China are preventing a needed facility...

Human Drugs

FDA Hits Ipsen with Complete Response on Palovarotene

FDA issues Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bon...

Human Drugs

Generic Drug Controlled Correspondence Revised Guidance

FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.

FDA General

ODT Launches Leadership Modernization Action Plan

FDA launches a digital technology Leadership Modernization Action Plan.

Human Drugs

5 Observations on Glenmark FDA-483

FDA releases the form FDA-483 issued following an inspection at the Goa, India-based Glenmark Pharmaceuticals drug manufacturing facility.

FDA Approves Rozlytrek Companion Diagnostic

FDA approves a Foundation Medicine blood-based companion diagnostic for Genentechs cancer drug Rozlytrek.

Biologics

Group Urges Postponement of Alzheimers Drug Decision

Public Citizen calls on FDA to postpone a 1/6-expected accelerated approval decision on a Biogen/Eisai Alzheimers drug until after an advisory committ...

Human Drugs

Build Flexibility into Pubertal Development Guidance: BIO

The Biotechnology Innovation Organization suggests modifications to an FDA draft guidance on measuring growth and evaluating pubertal development in p...