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Regulatory Review Period Determined for Inrebic

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Impact Biomedicines Inrebic...

ICH Looking to the Future

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The International Council on Harmonizations looks at changes it must make to evolve with the process of drug development in a chan...

ElZarrad Named CDER OMP Director

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CDER appoints M. Khair ElZarrad as director of the Office of Medical Policy.

Advisors on Makena Must be Fairly Balanced: Public Citizen

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Public Citizen calls on FDA to ensure that the membership of an advisory committee considering whether Covis Makena should be with...

Hulu Series on Oxycontin Hits Hard, Goes Easy on FDA

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Hulu launches an eight-part series on the Oxycontin epidemic that graphically lambastes Purdue Pharma but soft-pedals FDAs enablin...

Routine Vaccine Inspections May be Challenge: GAO

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The Government Accountability Office says FDA may be challenged in resuming routine surveillance inspections of vaccine and allerg...

Yale Working with FDA on Trial Diversity

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FDA contracts with the Yale School of Medicine to promote clinical trial awareness and access to underrepresented minorities.

FDA Breast Implant Safety Actions

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FDA says it has taken three new actions to strengthen the risk communication about breast implants and help consumers to make info...

Panel to Review Merck Covid Drug

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Federal Register notice: FDA announces an 11/30 Antimicrobial Drugs Advisory Committee meeting to review a Merck Emergency Use Aut...

CDRH Guidance Document Plans for FY 2022

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Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends ...