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Dara Wants Longer Tamoxifen Adjuvant Therapy

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Dara BioSciences asks FDA to increase the duration of adjuvant tamoxifen therapy for women with estrogen receptor-positive breast ...

FDA Alert Admitted as Evidence in Malpractice Case

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Attorney Steve McConnell criticizes a Tennessee federal court decision to admit into evidence in a medical malpractice case an FDA...

CDRH Supporting Devices for the Disabled: Maisel

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CDRH chief scientist William Maisel says the Center is working with medical device manufacturers to further development of innovat...

FDA OKs First Vaccine for Serogroup B Meningococcal Disease

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FDA approves Wyeth Pharmaceuticals Trumenba, the first vaccine in the U.S. to prevent invasive meningococcal disease caused by Nei...

FDA Sends Collection of Info on Biologic AERs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on adverse experience reporting for licensed biological ...

Collection of Info on Smokeless Tobacco Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the pH of smokeless tobacco products to the Office of...

Comments Sought on FDA-IND Sponsor Communication

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Federal Register Notice: FDA establishes a docket to receive recommendations on best practices for communication between FDA and I...

Ex-FDAer John Taylor Joins Regulatory Consulting Firm

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Former FDA counselor to the commissioner John Taylor joins Greenleaf Health as compliance and regulatory affairs principal.

FDA Refutes Takeda Safety Challenge Over Colcrys Competitor

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FDA says it did not err when it approved Hikma Pharmaceuticals 505(b)(2) application last month for Mitigare (colchicine) capsules...

Real World Data Help Effective Drug Use: Conference

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Presenters on a European Health Forum panel say real world data can change the way drugs are developed, approved, and prescribed.