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FDA Submits Info on Postmarket Reporting to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on applications f...

FDA Sends Info on Graphic Cigarette Labels

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Federal Register Notice; FDA submits a reinstatement collection on graphic cigarette labels to the Office of Management and Budget...

Meeting on Renewing Animal Drug User Fee Act

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Federal Register Notice: FDA plans a meeting 12/18 on the reauthorization of the Animal Drug User Fee Act.

R&D Rate of Return Still Falling

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A Deloitte analysis says that the internal rate of return for research and development in 12 leading drug companies fell for the s...

Appeals Court Backs Off-label Drug Promotions

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A federal appeals court ruling throws a wrench in FDAs use of off-label promotions as evidence of a pharmaceutical manufacturer's ...

Quality Violations at Huhui OTC Facility

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FDA warns Shanghai Huhui Daily Use Chemical Products Company of CGMP and other violations at its Shanghai, China, manufacturing fa...

FDA Grants Restriction on Lyrica ANDAs

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FDA grants a Pfizer request involving Lyrica ANDAs and denies two other requests.

Growing Interest for Breakthrough Drug Designations: Woodcock

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CDER director Janet Woodcock says her Center is seeing growing interest from pharmaceutical developers in taking advantage of a ne...

Zofran 32 mg IV Dose Being Pulled from Market

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FDA says it is working with manufacturers to recall the single 32 mg IV dose of Zofran due to the potential risk of serious cardia...

Q&A Guidance on FDA Oversight of Pet Drugs

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Federal Register Notice: FDA releases a guidance, FDA Oversight of PET Drug Products Questions and Answers.