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OGD Question-based Review for Sterility

[ Price : $8.95]

CDERs Office of Generic Drugs develops a question-based review module for Sterility Assurance Quality Overall Summary (SA-QOS) Ou...

FDA Finds 48 Quality Issues at Ben Venue

[ Price : $8.95]

FDA issues the FDA-483 from a May inspection at Ben Venue Laboratories detailing 48 quality concerns in the firms contract manufac...

Perrigo ANDA for Generic Patanase

[ Price : $8.95]

Perrigo Co. files an ANDA for olopatadine hydrochloride nasal spray, a generic copy of Alcon Labs' allergy nasal spray Patanase.

FDA Clears Hologic Specimen Radiography System

[ Price : $8.95]

FDA clears a Hologic 510(k) for the Trident specimen radiography system.

Plea Agreement for Liang on Inside Trading Charges

[ Price : $8.95]

CDER chemist Cheng Yi Lang pleads guilty to insider trading and making a false statement.

NCTRs Science Advisory Board to Meet

[ Price : $8.95]

Federal Register Notice; FDAs Science Advisory Board to the National Center for Toxicological Research will meet 11/8-9.

Latest FDA Warning Letters

[ Price : $8.95]

In it latest batch of Warning Letters, FDA cites Advantageous MD, Algonot, Jazz Pharmaceuticals, National Therapy Products, Nordim...

Vivus Resubmits NDA for Obesity Drug Qnexa

[ Price : $8.95]

Vivus resubmits an NDA for its Qnexa (phentermine/topiramate) obesity drug that proposes a narrower indication than previously sou...

FDA Clears Medtronic Aquamantys Surgical System

[ Price : $8.95]

FDA clears a Medtronic 510(k) for its Aquamantys 3 System and its 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pie...

FDA Clears ALR Tech Remote Monitor

[ Price : $8.95]

FDA clears an ALR Technologies 510(k) for its Health-e-Connect (HeC) System for remote patient monitoring in diabetes management p...