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Info Collection Extension for PET Drug GMPs

[ Price : $8.95]

Federal Register notice: FDA has submitted to OMB an information collection extension for positron emission tomography Drug GMPs.

Sharpless Supporters More Vocal

[ Price : $8.95]

Supporters of FDA acting commissioner Ned Sharpless urge the administration to nominate him as permanent commissioner.

Panel to Discuss Duodenoscope Sterilization

[ Price : $8.95]

Federal Register notice: FDA announces an 11/6-7 Advisory Committee meeting to discuss industrial ethylene oxide sterilization of ...

Chromatographic Bioanalysis Guidance

[ Price : $8.95]

FDA issues a guidance to make recommendations to sponsors, applicants, and contract research organizations on internal standard re...

Ex-FDAer Sherman Joins Aptinyx Board

[ Price : $8.95]

Former FDA principal deputy commissioner Rachel Sherman joins Aptinyxs board of directors.

Pediatric Labeling Changes for Sovaldi and Harvoni

[ Price : $8.95]

FDA summarizes labeling changes to Gileads Solvadi and Harvoni to add pediatric dosage forms.

FDA Warnings Yield Lower Chantix Use: Study

[ Price : $8.95]

Researchers say early FDA drug safety communications on Pfizers Chantix led to reduced prescribing in the VA health system, leadin...

Study Finds Better Adverse Events Filed by Consumers

[ Price : $8.95]

An new study suggests that FDAs 2013 move to a consumer-friendly adverse event reporting form has contributed positively to both t...

Info Collection Extension for ANADAs

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for Abbreviated New Animal Drug Applications.

FDA Required Post-Market Studies Empty Threat: Professor

[ Price : $8.95]

Canadian health professor Matthew Herder says FDAs power to withdraw a drug if its manufacturer fails to produce useful required p...