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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.

Info Corrected on Preoperative Skin Prep Products Hearing

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Federal Register Notice: FDA corrects a 11/21 notice on antiseptic patient preoperative skin preparation products.

Participants Sought to Select Device GMP Panelists

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Federal Register Notice: FDA seeks participants to select nonvoting industry representatives to serve on CDRHs Device Good Manufac...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Avis Dairy, Casmed, New Star Lasers, Shanghai Ruike Sports, Shanghai Huhui Daily...