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Comments on Labeling Requirements Sought

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Federal Register Notice: FDA seeks comments on requirements on content and format of labeling for human prescription drug and biol...

Cephalon Settles Off-label Promo Probe

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Cephalon agrees to pay $425 million to resolve criminal and civil charges over alleged off-label promotions involving Gabitril, Ac...

FDA Finds Statins Dont Increase Lou Gehrigs Disease

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An FDA analysis provides new evidence that statins do not increase the incidence of amyotrophic lateral sclerosis.

FDA Looking at Death Risk in Procrit Trial

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An FDA Early Communication says the agency is analyzing data from a German clinical trial showing there were more deaths in patien...

Indevus and FDA Come to Terms on Nebido Complete Response

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Indevus Pharmaceuticals and FDA reach an agreement on additional safety data and a risk management strategy that will be submitted...

Must Bioequivalence Trials be Registered?

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GPhA says Congress should act to specifically exclude bioequivalence studies from FDA Amendments Act requirements for clinical tri...

Guidance on End-of-Phase 2A Meetings

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Federal Register Notice: FDA releases a draft guidance on end-of-phase 2A meetings for IND sponsors who wish to utilize clinical t...

Approved PMA List Posted

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Federal Register Notice: FDA publishes its list of approved PMAs.

DDMAC Takes on 5 ADHD Drugs

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CDERs Division of Drug Marketing, Advertising, and Communications sends two Warning Letters and three untitled letters to manufact...

Medtronic Catheter Alert is Class 1 Recall

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FDA says a Medtronic safety alert in June on sutureless catheter connections with implantable drug infusion systems is a Class 1 r...