FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

5 Observations in Cipla FDA-483

FDA releases a form FDA-483 with five observations from an inspection at the Cipla drug manufacturing facility in Goa, India.

latest-news-card-1
Medical Devices

OIG Identifies FDA Emergency Use Authorization Issues

FDA concurs with six recommendations made by the HHS Inspector General to improve the EUA process for tests in a future pandemic.

latest-news-card-1
Human Drugs

FDA Approves Pedmark for Cisplatin Ototoxicity

FDA approves Fennec Pharmaceuticals Pedmark to treat cisplatin-associated ototoxicity in pediatric patients.

latest-news-card-1
Federal Register

Panel to Discuss Zejula Supplemental NDA

Federal Register notice: FDA announces an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (n...

latest-news-card-1
Human Drugs

FDA Approves New Contrast Agent

FDA approves a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent for use in contrast-enhanced magnetic resona...

Biologics

Catalent Hit With 12-item 483 on Moderna Vaccine

FDA issues contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firms Bloomington, IN facil...

latest-news-card-1
Medical Devices

Medtronic Cardiac Monitor Gets Expanded Use

FDA clears a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor system for expanded use in pediatric patients over the age of two years who h...

latest-news-card-1
Human Drugs

Merck Hold Lifted to Permit New HIV Trials

FDA lifts a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with ...

latest-news-card-1
Human Drugs

FDA Stepping Up Drug Inspections in India

FDA says its inspections in India are nearing pre-pandemic levels.

latest-news-card-1
Human Drugs

Getting Clinical Outcome Assessments into Endpoints Guide Coming

CDER associate director Theresa Mullin says FDA will soon release a draft guidance on Incorporating Clinical Outcome Assessments into Endpoints for Re...