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FDA Panel Backs Takeda BLA for Crohns, Ulcerative Colitis

[ Price : $8.95]

A joint FDA advisory committee votes to recommend approval for a Takeda Pharmaceutical BLA for vedolizumab and its use in treating...

FDA Inspection Finds Violations at Jubilant HollisterStier

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FDAs Seattle District Office warns Jubilant HollisterStier about CGMP violations in its manufacturing of finished pharmaceuticals....

PhRMA Wants FDAMA Section 114 Guidance

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PhRMA calls on FDA to issue guidance on how drug companies can disseminate healthcare economic data under FDAMA Section 114 withou...

AbbVie Study Shows 96% Response with Genotype 1 Hepatitis C

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AbbVie reports positive data from its SAPPHIRE-II study of a three direct-acting-antiviral regimen plus ribavirin in patients with...

FDA OKs New Dose for Zogenix Migraine Treatment

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FDA approves a Zogenix supplemental NDA for a 4 mg dose of Sumavel DosePro Needle-free Delivery System.

CDER Focusing on Increasing Data Integrity Problems

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CDER Office of Compliance deputy director Ilisa Bernstein says the Center plans to place more attention on data integrity problems...

FDA Sends Info on Device QSRs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on medical device current good manufacturing practice to...

Comments Sought on Periodic Safety Report Info

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Federal Register Notice: FDA seeks comments on an information collection associated with submission of periodic safety reports for...

Guidance on Size, Shape of Generic Tablets, Capsules

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Federal Register Notice: FDA releases a draft guidance: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules...

Latest FDA Warning Letters

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In it latest batch of Warning Letters, FDA cites Ameriderm Laboratories, Jubilant HollisterStier, Market Technologies Inc. dba Der...