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Team Wins $40,000 in Naloxone App Competition

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FDA associate commissioner Peter Lurie says the winner of an FDA-sponsored Naloxone App Competition was OD Help, created by Team P...

Professional E-mail Misbrands Renacidin

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CDERs Office of Prescription Drug Promotion warns United-Guardian about a professional e-mail that misbrands its Renacidin.

Woodcock: Business as Usual as New Administration Looms

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CDER director Janet Woodcock says she is not too concerned with an Administration change next month, saying that for now it is bus...

Reject Innovator Theory of Liability: WLF

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Washington Legal Foundation asks the California Supreme Court to reject a theory of innovator liability a lower state court used t...

FDA Names Solomon to Head CVM

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FDA names deputy associate commissioner for regulatory affairs Steven M. Solomon, DVM, as the new Center for Veterinary Medicine d...

Guidance on Electronic Informed Consent Q&A

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Federal Register Notice: FDA and HHSs Office for Human Research Protections make available a guidance entitled Use of Electronic I...

Osmotica Asks BE Test for Venlafaxine

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Osmotica asks FDA to require in vivo ANDA bioequivalence testing for the 225 mg strength of its venlafaxine HCl.

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...