FDA Related News

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...

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

4 CGMP Violations in Huons Inspection

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

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.

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...

Human Drugs

FDA Bought Unapproved New Drugs on Amazon

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

FDA General

Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership

Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the p...

Human Drugs

Jubilant HollisterStier CGMP Issues

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

Human Drugs

Nicotine Dependence NDA Gets Complete Response Letter

FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.

Human Drugs

Pharmaneek Inspection Form FDA-483 Out

FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.