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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...

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...

Suggestions Made for Informed Consent Guidance

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Stakeholders say an FDA draft guidance on the informed consent information sheet may lead to a document that is too complex for ma...

Bill to Speed Ebola Treatments Coming

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Sens. Harkin and Alexander say they will introduce legislation to add Ebola to the list of qualifying tropical diseases for an FDA...

Multiple Violations Found in Vitalab Inspection

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FDAs Kansas City District Office warns Vitalab about many violations in its manufacturing and distribution of dietary supplements....

Pull Draft Risk Info Guidance: Patient Group

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Industry and consumer groups say they differ on the value of an FDA draft guidance on communicating new risk information to health...

Best Practices with FDA for Firms During Drug Development

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FDA plans a draft guidance on best practices for communications between agency reviewers and drug sponsors during product developm...