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Comments Sought on Drug Shortages

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Federal Register Notice: FDA opens a comment period on the topic CDER addresses in a 9/26 public workshop, drug shortages.

CBER Seeks Vaccine Panel Nominations

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Federal Register Notice: FDA seeks industry organizations interested in helping select representatives for CBER Vaccines advisory ...

Cubist to Initiate Phase 3 Trials for C. Difficile Product

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Cubist Pharmaceuticals plans Phase 3 clinical trials of its therapy to treat Clostridium difficile-associated diarrhea.

FDA Targets 717 Web Sites in Illegal Marketing Operation

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FDA and other regulatory and international partners complete a week-long Internet crackdown on producers and distributors of count...

FDA Clears 2 Army Influenza Test Kits

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FDA clears U.S. Army Office of the Surgeon General 510(k)s for two Influenza test kits and their use with Idaho Technology's Joint...

FDA Classifies Pathway Genetic Kit as Class I

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FDA classifies Pathway Genomics genetic testing kit, blocked last year from OTC sale at Walgreens drug stores, as a Class 1 exempt...

CDRH Remaking IDE Process: Maisel

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CDRH chief scientist William Maisel says the Center is planning to release three guidance documents this fall to help improve its ...

Little Evidence for Off-label Atypical Antipsychotic Use

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HHS researchers say they found little evidence supporting many off-label uses of atypical antipsychotics.

Transcept Resubmits Intermezzo NDA

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Transcept resubmits its Intermezzo NDA to FDA following a meeting with FDA staff.

CDER Chemist Faces New Charges

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CDER chemist Chang Liang has been charged with one count each of insider trading, making false statements, and aiding and abetting...