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Humanitarian Use Devices Info Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on humanitarian use devices to the Office of Management an...

Closed Advisory Panel Meetings Reports Filed

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Federal Register Notice: FDA files the annual reports of FY 2008 closed advisory committee meetings with the Library of Congress.

Workshop on Contact Lens Products

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Federal Register Notice: FDA co-sponsors a public workshop 1/22-23/09 on test method parameters for evaluating the activity of con...

FDA Needs a Leader Strong Enough to End its Chicanery

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Washington commentator Robert Steeves calls on the Obama administration to give FDA a commissioner strong enough to end its ingrai...

FDA Death Data on Heparin is Refuted: Barton

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Texas Republican Joe Barton again challenges FDAs handling of the contaminated heparin issue, saying he has new information refuti...

Guidance on Drug Genotoxic and Carcinogenic Impurites

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Federal Register Notice: FDA releases a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Rec...

Comments Sought on Postmarketing AER Requirements

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Federal Register Notice: FDA seeks comments on postmarket adverse drug experience reporting and recordkeeping requirements.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Contract Medical Manufacturing, Goosefoot Acres, Neuro Kinetics, and Steritec Pr...

Guidance on Drug Genotoxic and Carcinogenic Impurities

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CDER issues a draft guidance on evaluating drug impurity safety during clinical development and marketing.

Not All Trial Data Are Published

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Researchers say that only 78% of clinical trials submitted to FDA in marketing applications are published, meaning that healthcare...