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FDA Extends Comment Period on Off-label Info Review

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FDA extends until 4/10/2017 the comment period on its initiative to review Manufacturer Communications Regarding Unapproved Uses o...

More Complete Response Letters, Fewer Drug Approvals: Jenkins

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Retiring Office of New Drugs director John Jenkins says CDER is issuing more complete response letters this year, and it is signif...

FDA, OHRP Guide on Electronic Informed Consent

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FDA and HHS Office for Human Research Protections release a guidance on Use of Electronic Informed Consent (eIC) Questions and An...

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Stakeholders urge major revisions to an FDA draft guidance on software as a medical device that incorporates an International Medi...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