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Watson Pulls Generic Wellbutrin XL 300 MG

[ Price : $8.95]

FDA says Watson is withdrawing its generic Wellbutrin XL 300 mg drug after tests found it was not bioequivalent to the branded dru...

Congresswoman Planning Mobile Medical App Bill

[ Price : $8.95]

Rep. Marsha Blackburn says she is writing legislation to give FDA more authority and resources for regulating mobile medical apps.

FDA Licenses GastroPlus Simulation Software

[ Price : $8.95]

FDA licenses Simulations Plus GastroPlus for use in CDERs Office of Clinical Pharmacology.

FDA Awards Contract on Opioid Formulation Effects

[ Price : $8.95]

FDA awards the National Institute for Pharmaceutical Technology and Education a $500,000 two-year contract to examine formulation ...

Catalyst Gains Go Ahead from Data Monitors on Firdapse Study

[ Price : $8.95]

An independent data monitoring committee recommends that Catalyst Pharmaceutical Partners to continue as planned an ongoing pivota...

FDA OKs Omeros Pediatric Study Plan for OMS302

[ Price : $8.95]

FDA approves an Omeros Corp. Pediatric Study Plan to study OMS302 (phenylephrine and ketorolac) in pediatric patients undergoing p...

FDA Issues Bacterial Endotoxins Test Guidance

[ Price : $8.95]

FDA issues an International Conference on Harmonization expert working group guidance on the bacterial endotoxins test general cha...

Medical Device eCopy Guidance Out

[ Price : $8.95]

FDA issues a clarifying guidance on medical device eCopy submission.

FDA Publishes Draft Guidance on Elemental Impurities

[ Price : $8.95]

FDA issues a draft guidance on controlling elemental impurities in drug products.

B. Braun Recalls Injectable for Visible Organic Particulates

[ Price : $8.95]

FDA issues a MedWatch safety alert to pharmacies and consumers on a B. Braun Medical recall of one lot of cefepime for injection a...