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Grassley Questions Artificial Blood Trial Ethics

[ Price : $8.95]

Sen. Chuck Grassley wants an HHS ethics advisory committee to look into whether informed consent waivers would include emergency r...

PharmDaily Launches Consumer Health Web Site

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PharmDaily.com launches a new consumer health Web site that also is open to drug company advertising,

Public Citizen Says Mentor Withheld Data

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Public Citizen calls for an FDA criminal investigation into a whistleblowers claim that Mentor withheld important breast implant s...

Nominations Sought for Device Panels

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Federal Register Notice: FDA requests nominations for voting members to serve on several device advisory panels and the Mammograph...

Review Period Corrected for Boniva

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Federal Register Notice: FDA corrects the regulatory review period for Roche/GlaxoSmithKlines Boniva for patent extension as 3,122...

Implement IoM Safety Ideas: NEJM

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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...