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FDA OKs Novartis sNADA for Swine Diseases

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Federal Register Final rule: FDA approves a Novartis Animal Health supplemental NADA for using an increased strength of tiamulin c...

Special Controls Guidance on Coronary Angioplasty Catheters

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Federal Register Notice: FDA releases a special controls guidance for certain percutaneous transluminal coronary angioplasty cathe...

FDA Review Process Blocking New Antimicrobials: Speaker

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UCLA medicine professor Brad Spellberg tells an IoM workshop that FDA requirements are preventing more development of novel antimi...

Review Period Set for Effient

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Federal Register Notice: FDA determines the regulatory review period for Daiichi Sankyos Effient for the purpose of patent extensi...

Guidance on Vaccine Bar Code Labels

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Federal Register Notice: FDA releases a draft guidance on bar code label requirements for licensed vaccine manufacturers.

CBER Announces Blood eSubmitter Pilot Program

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Federal Register Notice: CBER invites participants in its eSubmitter Program, an automated BLA and BLA supplement submission syste...

Review Period Set for Bryan Cervical Disc System

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Federal Register Notice: FDA determines the regulatory review period for Medtronics Sofamor Daneks Bryan Cervical Disc System for ...

Two Idenix Drug Development Programs on Hold

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FDA puts two Idenix Pharmaceuticals hepatitis C drug development programs on clinical hold due to reports of serious adverse event...

Public Meeting on Efficacy Under the Animal Rule

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Federal Register Notice: FDA plans a public meeting 11/5 on issues addressed in the guidance on animal models and the essential el...

Workshop on Pediatric Cell and Gene Therapy Trials

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Federal Register Notice: CBER plans a public workshop 11/2, Cell and Gene Therapy Clinical Trials in Pediatric Populations.