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FDA Iron Sucrose Guidance Challenged

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Luitpold Pharmaceuticals and four patient advocacy groups question an FDA draft guidance on determining bioequivalence for generic...

FDA Posts August NADA Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect August NADA approvals and to reflect sponsor change...

FDA Posts Approved PMAs

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Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.

Drug Companies Obliged to Publicize Drug Risks: Kessler

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Former FDA commissioner David Kessler says that doctors are unduly influenced by drug company promotional activities.

FDA OKs Sigma-Tau Pharma Cystaran Ophthalmic Therapeutic

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FDA approves Sigma Tau Pharmaceuticals Cystaran 0.44%, a topical ophthalmic therapeutic for treating corneal cystine crystal accum...

FDA Shuts Down 4,100 Illegal Internet Pharmacies

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FDA, in partnership with international regulatory and law enforcement agencies, takes enforcement actions this week against more t...

FDA Clears Covidien Respiratory Monitor

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FDA clears a Covidien 510(k) for the Nellcor Bedside Respiratory Patient Monitoring System.

Refuse to Accept Guidance Needs Changes: Comments

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Medical device manufacturers and advocacy groups suggest changes and clarifications they believe are needed in FDAs draft guidance...

OGD Procedure for Major/Minor Amendments

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The Office of Generic Drugs gives chemistry reviewers a MAPP with additional information and examples on determining major and min...

HHS Inspector General Will Look at REMS Implementation

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The HHS Inspector General lists five FDA activities it will examine in its FY 2013 work plan.