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Using Social Media for Drug Adverse Event Trends

[ Price : $8.95]

Researchers are using a National Science Foundation grant to determine whether social media postings can be used as an adverse dru...

Extend Marketing Exclusivity for Some Drug Combinations?

[ Price : $8.95]

Reps. Bilbray, Maloney, and DeLauro introduce legislation to provide additional exclusivity for drugs designated by FDA as signifi...

FDA Withdraws Approval of NADA, 3 ANADAs

[ Price : $8.95]

Federal Register Final rule: FDA amends the animal drug regulations to withdraw approval of one NADA and three ANADAs because they...

CDER Plans Clinical Investigator Training Course

[ Price : $8.95]

Federal Register Notice: CDER will co-sponsor a training course 11/13-15 for clinical investigators in College Park, MD.

Oncologists Doing Most with Social Media

[ Price : $8.95]

A OneKey analysis of healthcare practitioner use of social media finds that oncologists are more active in social media than other...

Celltex to Appeal FDA Product Designation

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Celltex Therapeutics says it will appeal a recent FDA decision that the process it uses to multiply adult stem cells is subject to...

6-year Generic Wellbutrin Puzzle Solved; Teva Product Pulled

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An FDA-commissioned bioequivalence study of Tevas Budeprion XL 300mg ends six years of controversy over adverse effects in patient...

Study Says Pediatric Exclusivity Pays Off

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A new study says that pediatric drug exclusivity strategies can see a return-on-investment on average of $130 for every $1 spent.

Medtronic Gets FL Case Dismissed on Preemption Grounds

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A Florida federal judge grants a Medtronic motion to dismiss on preemption grounds in a product liability suit involving the compa...

FDA Cancels Panel Meeting on Celgenes Pomalidomide

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FDA tells Celgene that it has canceled an 11/8 Oncologic Drugs Advisory Committee meeting that was intended to review the companys...