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FDA Guide on Bronchitis Drugs

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FDA releases a new guidance intended to assist sponsors in the clinical development of antimicrobial drugs indicated for treating ...

Passive Implant Testing and Labeling

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CDRH issues a guidance on testing and labeling of passive implants for safety and compatibility in the magnetic resonance environm...

FDA Clears Radiation Treatment Software

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FDA clears a CMS, Inc. 510(k) for its Atlas-Based Autosegmentation product, a software-based product used for creating a radiation...

FDA/PDA Joint Meeting

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Federal Register Notice: FDA plans a joint regulatory conference 9/8-12 on such topics as the Global Harmonization Task Force and ...

J&J Gets First Complete Response Letter on Antibiotic

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Johnson & Johnson Pharmaceutical Research & Development receives the first complete response letter from FDA on an NDA for antibac...

FDA Updates USP Residual Solvents Info

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CDERs Office of Generic Drugs clarifies information to be submitted to fulfill the revised USP chapter on residual solvents.

GSK to Report Grant Spending

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GlaxoSmithKline says it will begin next February reporting on educational and charitable grants it makes to a variety of organizat...

Appeals Court Reverses FD&C Act Conviction

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The Third Circuit Court of Appeals has reversed a felony conviction under the FD&C Act for selling prescription veterinary drugs w...

FDA Denies Cardiolite ANDA Petition

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FDA denies Bristol-Myers Squibbs citizen petition asking that specific requirements be placed on ANDA applicants for generic Cardi...

Court Rejects Preemption of Food Suit

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The Third Circuit Court of Appeals says a state failure-to-warn suit over the risk of mercury poisoning in seafood is not preempte...