FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Biologics

JAMA Publishes Previously Blocked Covid-19 Vaccine Study

JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...

latest-news-card-1

FDA FY 2027 Appropriation Report Analyzed

Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectations for the FY 2027 ...

latest-news-card-1
Human Drugs

FTC Weighs in Against J&J in Stelara Monopoly Case

The Federal Trade Commission files an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unlawfully maintaining ...

latest-news-card-1
Human Drugs

FDA Details Standardized Approach to Drug Safety Signal Detection

A new CDER Office of New Drugs webinar discusses the development and use of OND Custom Medical Queries to identify potential safety signals during rev...

latest-news-card-1
Medical Devices

Require IDE for Venas MicroAngioscope: Petition

Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena MicroAngioscope and take other steps to determine if...

Human Drugs

Jubilant HollisterStier CGMP Issues

FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.

latest-news-card-1
Human Drugs

4 CGMP Violations in Huons Inspection

FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.

latest-news-card-1

FDA Leadership Upheaval Yields Uncertainty: Post

A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.

latest-news-card-1
Medical Devices

FDA Issues Early Alert on Abiomed Impella Introducer Kits

FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pu...

latest-news-card-1
Human Drugs

FDA Bought Unapproved New Drugs on Amazon

FDA warns Amazon it is marketing unapproved new drugs on its Web site.