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CDRH Guidance on Posting Device Emerging Signals

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Federal Register Notice: FDA makes available a guidance entitled Public Notification of Emerging Postmarket Medical Device Signals...

Listing of Information Collections Approved by OMB

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Federal Register Notice: FDA makes available a list of information collections that have been approved by the Office of Management...

Public Meeting on Developing Sarcopenia Therapies

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Federal Register Notice: FDA announces a 4/6/2017 public meeting on Patient-Focused Drug Development for Sarcopenia.

FDA Approves New Eczema Drug

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FDA approves an Anacor Pharmaceuticals NDA for Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis)...

AdvaMed Wants Changes in Software Guidance

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Stakeholders urge major revisions to an FDA draft guidance on software as a medical device that incorporates an International Medi...

FDA has LASIK Assessment Questionnaire

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CDRHs Malvina Eydelman says a new FDA Web-based LASIK questionnaire can be used to assess patients before and after surgery.

Cures Act Drug Regulatory Changes Summarized

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Hogan Lovells attorneys summarize 21st Century Cures provisions relating to regulation of drugs and biologics.

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...