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Priority Review for Genentech Tecentriq sBLA

[ Price : $8.95]

FDA accepts for priority review a Genentech sBLA for a new indication for its Tecentriq.

Regulatory Review Period for Aspire Assist Device

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Aspire Bariatrics medical d...

Regulatory Review Period for Synergys Trulance

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Synergy Pharmaceuticals Tru...

Regulatory Review Period for Intercepts Ocaliva

[ Price : $8.95]

FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid)...

QS Issues at MiBo Medical Group

[ Price : $8.95]

FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.

CGMP Violations in Barox Inspection

[ Price : $8.95]

FDA warns Koreas Barox about CGMP violations in its production of finished drugs.

FDA Recognizes Genetic Public Database

[ Price : $8.95]

FDA says its recognition of the ClinGen genetic data database will help speed development of novel diagnostic technologies to diag...

FDA Evaluating Mass Spectrometry in Drug Quality Control

[ Price : $8.95]

FDA says its researchers are evaluating a way to use mass spectrometry in drug quality control.

Draft Guide on Noncirrhotic Nonalcoholic Steatohepatitis Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibros...

Guide on ANDA Post-Complete Response Letter Meetings

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA...