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Comments Sought on Tobacco Regulation, Marketing

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Federal Register Notice: FDA seeks comments on agency meetings with tobacco manufacturers, etc. on their plans to research the reg...

Comments Sought on Notification for GRAS Substances

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Federal Register Notice: FDA seeks comments on: Substances Generally Recognized as Safe: Notification Procedure 21 CFR 170.36 and...

Panel to Discuss Pediatric Development for Cancer Drugs

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Federal Register FDAs Pediatric Oncology Subcommittee will meet 11/19 to discuss potential pediatric development plans for two pro...

PhRMA Strongly Supports PDUFA

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PhRMA voices support for PDUFA and changes it wants in PDUFA 6.

Opioid Epidemic Study Results Sought

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36 advocacy groups ask the Senate Finance Committee to release results of a probe into the connection between drug companies and g...

NORD 2011 Petition Granted, Denied in Part

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FDA grants in part and denies in part a National Organization for Rare Disorders petition seeking acknowledgment of special circum...

CDER Data Standards MAPP

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CDER issues a policies and procedures manual on its data standards program.

Thoratec Urgent Device Correction for HeartMate II

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Thoratec issues an Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II Left...

FDA Gives Breakthrough Status for Opdivo

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FDA grants Bristol-Myers Squibb a breakthrough therapy designation for Opdivo for treating advanced or metastatic renal cell carci...

Adverse Drug Reports Incomplete, Inaccurate: Tufts

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The Tufts Center for the Study of Drug Development says that many drug adverse event reports are incomplete or inaccurate, causing...