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Senators Urge FDA to Strengthen Opioid Studies

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Senators Edward Markey (D-MA) and Joe Manchin (D-WV) call on FDA to curb the use of enriched enrollment randomized withdrawal stud...

Legislation Introduced to Improve Device Recalls

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U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legislation to improve the medical de...

Panel Votes Down Intarcia Diabetes Implant

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics implantable ITCA ...

PDUFA Formal Meeting Guidance

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FDA publishes a draft guidance with recommendations about formal meetings between FDA and sponsors or applicants relating to drugs...

Drug Manufacturing Alternative Assessment Tools

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FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs,...

Travere Filing sNDA for Filspari Full Approval

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Travere Therapeutics says confirmatory trial data for accelerated approval therapy Filspari (sparsentan) will form the basis of a ...

Guidance on ISO-10993-1 Explained

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Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international standard for medical device bio...

Ozempic Mental Health Issues Up: NPR

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An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide dru...

Merck sBLA for Keytruda Use in Cervical Cancer

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam r...

Orphan Drug Designation for Pumas Alisertib

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FDA grants orphan drug designation to Puma Biotechnologys small cell lung cancer investigative drug aliserib.