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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...

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FDA Publishes Draft Guidance on Elemental Impurities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FDA issues a draft guidance on controlling elemental impurities in drug products.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...

Court Dismisses 1, Partially Dismisses Another Infuse Case

[ Price : $8.95]

A California federal court dismisses a case against Medtronic because it was filed later than the statute of limitations and allow...

MannKind Re-files NDA for Afrezza

[ Price : $8.95]

MannKind resubmits an NDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder, indicated for improving glycemic control in...

Ex-FDA Head McClellan Joins J&J Board

[ Price : $8.95]

Former FDA commissioner Mark McClellan joins Johnson & Johnsons board of directors.

FDA Approves Tevas Generic Tobi

[ Price : $8.95]

FDA approves a Teva Pharmaceutical Industries ANDA for a generic copy of Novartis Tobi (tobramycin) inhalation solution.