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Mammography QA Committee to Meet

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Federal Register Notice: FDA plans a meeting 9/15 of the National Mammography Quality Assurance Advisory Committee to discuss comp...

AbbVie Sues Amgen Over Humira Biosimilar

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AbbVie files suit against Amgen to block its biosimilar version of AbbVies blockbuster arthritis therapy Humira.

Merck Files NDA for Follow On Lantus Product

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FDA accepts a Merck NDA for MK-1293, an investigational follow-on biologic copy of Sanofi-Aventis Lantus (insulin glargine) for us...

BMS Reports Opdivo Trial Misses Primary Endpoint

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Bristol-Myers Squibb reports disappointing data from its CheckMate-026, a trial investigating the use of Opdivo (nivolumab) as mon...

FDA, Amarin Amend Protocol in Vascepa Outcomes Study

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FDA and Amarin agree to amend the companys special protocol assessment agreement for the REDUCE-IT cardiovascular outcomes study i...

Real-World Guidance Needs FDA Openness: Attorneys

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Hogan Lovells attorneys say a new FDA draft guidance indicates the agencys willingness to consider using real-world evidence and d...

BIO Considerations for Truthful Speech

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BIO publishes four bioethical considerations to focus its advocacy around truthful and non-misleading product communication.

Info on DTC Advertising Survey Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a national direct-to-consumer survey to the Office of...

Comments Sought on FOIA Certification

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Federal Register Notice: FDA seeks comments on a collection of information on certification of identity for Freedom of Information...

Guidance on Compounding Facilities Insanitary Conditions

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Federal Register Notice: FDA releases a draft guidance: Insanitary Conditions at Compounding Facilities.