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Guidance on Pharmacology for Drug/Biologic Pediatric Studies

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: General Clinical Pharmacology Considerations for Pediatric Studies for Dru...

Comments Extended on CMC Guidance

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period for a draft guidance on two-phased chemistry, manufacturing, and controls ...

Guidance on Bacterial Testing of Platelets

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Bacterial Detection Testing by Blood Collection Establishments and Transfu...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Autopista, Fioravanti Custom Products, LLC dba Essential Wholesale & Labs US Inf...

Bill Would Change FDA Expanded Access Program

[ Price : $8.95]

Rep. Michael McCaul introduces legislation to reform FDAs compassionate use policy.

Alere Corrects Testing System for Monitoring Warfarin Therapy

[ Price : $8.95]

Alere Inc. begins a voluntary correction to inform U.S. users of the Alere INRatio and INRatio 2 PT/INR Monitor system about certa...

FDA Clears CenterVue 510(k) for Confocal Scanner

[ Price : $8.95]

FDA clears a CenterVue 510(k) for its Eidon color confocal scanner, an automated retinal imaging system that combines confocal sca...

Critically Examine FDA Engagement Processes: MS Society

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Stakeholders urge FDA to continue to look for better ways to engage patients in providing information to the agency for use in pro...

Guidance on Rx Drug Distributor Annual Reporting

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Drug Supply Chain Security Act Implementation: Annual Reporting by Prescri...

Panel to Discuss Ferring NDA to Treat Nocturia

[ Price : $8.95]

Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 1/12/15 to discuss a Ferring Pharma ...