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New FDA Anesthetic and Sedation Drugs Warning

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FDA says it is requiring Warnings on labels of general anesthetics and sedation drugs about the risk of childrens brain developmen...

Most OTC Drug Warnings Subject to Preemption: Attorney

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Attorney James Beck says that preemption of state law failure-to-warn claims applies to OTC drugs in many instances, in the same w...

Toujeo TV Ad False, Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says a Sanofi TV ad for Toujeo makes false or misleading representations about the dru...

TV Spot Creates Otezla Misleading Safety Impression: OPDP

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CDERs Office of Prescription Drug Promotion says that a Celgene TV ad for Otezla undermines communication of important risk inform...

FDA Taps DoJ Lawyer for CDER Compliance Head

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FDA selects Department of Justice Office of International Affairs attorney Donald D. Ashley as CDERs next Office of Compliance dir...

Final Guidance on Device Emerging Signals

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FDA finalizes a guidance on Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) that describes CD...

CDRH Clarifies When Device MDR Reporting is Required

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A CDRH conference call clarifies when medical device firms are required to file Medical Device Reporting submissions and answers q...

Comments Sought for New Blood Donor Questionnaire

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Federal Register Notice: FDA seeks comments on a new information collection related to Donor Risk Assessment Questionnaire for FDA...

Regulatory Review Period for GSKs Nucala

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Federal Register Notice: FDA determines the regulatory review period for patent extension purposes of GlaxoSmithKlines Nucala (mep...

FDA Corrects Foreign Drug Registration Notice

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Federal Register Final Rule Correction: FDA corrects a final rule entitled Requirements for Foreign and Domestic Establishment Reg...