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Implement IoM Safety Ideas: NEJM

[ Price : $8.95]

A New England Journal of Medicine editorial and commentary call for prompt congressional action to implement the Institute of Medi...

No FDA Money to Check All SUD Reusers

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CDRH director of regulatory affairs Larry Spears says the agency doesnt have enough resources to regulate reprocessing of single-u...

More Drug Safety Money Coming: Gottlieb

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FDA deputy commissioner Scott Gottlieb says more money will be allocated to drug safety in coming budgets.

CDER Guide on Investigating OOS Results

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CDER explains its current thinking on how to investigate out-of-specification test results in a new final guidance.

Glaxo Seeks Expanded Label for Advair

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GlaxoSmithKline submits a supplemental NDA for expanded labeling on its Advair Diskus to reflect data showing a reduction in the r...

FDA Wants More Data on Needle-free Fuzeon

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Roche and Trimeris delay an amended supplemental NDA for a needle-free administration of HIV therapy Fuzeon after FDA requests add...

Disagreement on FDAs Nanotechnology Needs

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An FDA-sponsored public meeting on nanotechnology, draws conflicting testimony on the need for new legal/regulatory authorities.

DeCode Suspends Trial Due to Manufacturing Concern

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DeCode Genetics suspends a Phase 3 clinical trial involving its heart attack prevention drug in order to address an unexpected for...

CGMP Problems Found at Thermoplastic

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An FDA Warning Letter cites 14 CGMP problems found in an inspection at Irvine, CA-based Thermoplastic Comfort Systems.

FDA OKs Mercks Skin Cancer Drug

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FDA approves Mercks Zolinza (vorinostat), a once-daily drug for treating cutaneous manifestations in patients with cutaneous T-cel...