FDA Related News

Medical Devices

Software Precertification Program Comments

Two stakeholders make suggestions for revising the FDA software precertification working model.

Covidien Settling False Claims Act Case for $17 Million

The Justice Department says Covidien is paying more than $17 million in settle False Claims Act whistleblower allegations that it illegally provided s...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Anicare Pharmaceutical, Jubilant Life Sciences, Laboratorios Quantium and Pfizer (Hospir...

Human Drugs

FDA OKs Alkem Labs Generic Diovan to Help Shortages

FDA approves an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker that treats high blood pressure an...

Human Drugs

Biocon FDA-483

FDA releases the FDA-483 with two observations from an inspection at Indias Biocon Limited.

Medical Devices

FDA Qualifies 1st Biomarker Test Tool Type

FDA qualifies a software module to help develop medical devices to treat traumatic brain injury.

Human Drugs

FDA Expands Use of Regenerons Dupixent for Dermatitis

FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis wh...

Medical Devices

FDA Blocks PMA Approvals from Integra Subsidiary

FDA sends an Integra LifeSciences a Warning Letter blocking PMA approvals due to quality systems issues at a Boston manufacturing facility.

Federal Register

Comments Sought on Info Collection for Export Letters

Federal Register notice: FDA is seeking comments on an information collection entitled Export of Medical Devices; Foreign Letters of Approval.