FDA Related News

Human Drugs

Alternate Electronic Format Guidance

FDA publishes a draft guidance recommending ways to provide regulatory submissions

FDA Postpones Foreign Inspections Until May

FDA postpones foreign inspection of regulated products until May due to the coronavirus outbreak.

Federal Register

GI Drugs Advisory Committee Renewal

Federal Register notice: FDA announces the renewal of its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the current cha...

Human Drugs

CGMP Violations at Guangzhou Tinci

FDA warns Chinas Guangzhou Tinci about CGMP violations in its production of finished pharmaceuticals.

Medical Devices

FDA Explains Covid-19 Test Guidance

A CDRH Webinar explains provisions of an immediately-in-effect guidance on coronavirus tests developed in certain certified laboratories.

Human Drugs

AnaBios, FDA Study Human Primary Cardiomyocytes

AnaBios and FDA sign a research collaboration agreement to study adult human primary cardiomyocytes as a reference for cellular properties and drug-in...

Human Drugs

PhRMA Lays Out Opposition to Drug Importation Rule

In an 81-page letter, PhRMA explains its opposition to an FDA proposed rule to establish a process to permit some drug importation.

Medical Devices

HeartWare Ventricular Assist Device Battery Charger Recall

HeartWare recalls (Class 1) its Ventricular Assist Device system battery charger due to the potential for the charger to be mistakenly inserted into t...

Human Drugs

Members of Congress Want Clinical Trial Process Changes

Some 41 members of Congress ask FDA commissioner Stephen Hahn to implement a new guidance on developing treatments for ALS.

Medical Devices

Gottlieb Hits Federal Corona Virus Lack of Urgency

Former FDA commissioner Scott Gottlieb says the federal government was late in bringing academic and private laboratories into the process of coronavi...