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Drug Safety Oversight Board MAPP

[ Price : $8.95]

CDER publishes a MAPP on the Drug Safety Oversight Boards organization, roles, and responsibilities.

Roll Back Drug Company Monopolies: Engelberg

[ Price : $8.95]

Former generic drug industry counsel Alfred Engelberg says that the next president and Congress should roll back several drug comp...

Oncology Drug Web Sites Have Quantitative Info: FDA Study

[ Price : $8.95]

FDA researchers say that Rx oncology drug Web sites contain significant quantitative information about the drug benefits and less ...

Comments Sought on Antimicrobials Used in Animal Feed/Water

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on establishing appropriately targeted durations of use for antimicrobial drugs which ...

OPDP Says Investigational Remoxy Promoted on Web

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says Durect and Pain Therapeutics are illegally promoting Remoxy ER while it is still ...

Limits of Device Preemption Described

[ Price : $8.95]

Attorney Cliff Rieders looks at cases in which state tort claims against medical device manufacturers were not preempted by federa...

FDA Import Operation Chief Leaves FDA for Law Firm

[ Price : $8.95]

After a 24-year career, FDA Division of Import Operations director Domenic J. Veneziano leaves the agency to join international tr...

Petition Seeks Ban on Antibiotics in Livestock/Poultry

[ Price : $8.95]

Several public health groups petition FDA asking that it withdraw approval of the use of medically important antibiotics in livest...

WLF Wants Court Jurisdiction Decision Tossed

[ Price : $8.95]

Washington Legal Foundation asks a federal appeals court to overturn a lower court ruling allowing out-of-state plaintiffs to sue ...

Array Gains SPA for Colon Cancer Therapy

[ Price : $8.95]

Array BioPharma reaches agreement with FDA on a special protocol assessment related to BEACON CRC, a global Phase 3 trial involvin...