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Guide on Diabetes Drug Safety Evaluations

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Type 2 Diabetes Mellitus: Evaluating the Safety of New Drug...

Alternate Electronic Format Guidance

[ Price : $8.95]

FDA publishes a draft guidance recommending ways to provide regulatory submissions

FDA Postpones Foreign Inspections Until May

[ Price : $8.95]

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

GI Drugs Advisory Committee Renewal

[ Price : $8.95]

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

CGMP Violations at Guangzhou Tinci

[ Price : $8.95]

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

FDA Explains Covid-19 Test Guidance

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

AnaBios, FDA Study Human Primary Cardiomyocytes

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AnaBios and FDA sign a research collaboration agreement to study adult human primary cardiomyocytes as a reference for cellular pr...

PhRMA Lays Out Opposition to Drug Importation Rule

[ Price : $8.95]

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

HeartWare Ventricular Assist Device Battery Charger Recall

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

Members of Congress Want Clinical Trial Process Changes

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