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Guidance on Limiting Phthalates as Excipients in Drugs/Biologics

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Federal Register Notice: FDA releases a guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.

FDA Proposes to Revise Animal Drug Regs for Tolerances/Residues

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Federal Register Proposed rule: FDA proposes to revise the animal drug regulations to standardize, simplify, and clarify the deter...

CDRH Lists 6 Strategic Priorities

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CDRH releases its six strategic priorities for 2013.

FDA, AstraZeneca Agree on Faslodex Label Update

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FDA and AstraZeneca reach agreement on label changes for Faslodex injection that updates results from the companys CONFIRM trial i...

FDA Approved 35 NMEs in 2012

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An FDA report discusses the 35 new molecular entities the agency approved in FY 2012.

Lawyers Examine Future of FDA Enforcement Actions

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Lawyers from Skadden and Foley Hoag examine the future of FDA and Justice Department enforcement actions in the wake of this weeks...

FDA, Peregrine Reach Agreement on Brain Cancer Trial

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FDA and Peregrine Pharmaceuticals reach agreement on the design of a single registration drug trial for Cotara in patients with re...

FDAs Staggering Strategic Blunder in Off-label Case

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FDA Webview editor Jim Dickinson analyzes FDAs loss of a potent off-label drug marketing case, calling it a staggering strategic b...

FDA Approves Mylans Generic Atacand HCT

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FDA approves a Mylan Pharmaceuticals ANDA for candesartan cilexetil and hydrochlorothiazide tablets, a generic copy of AstraZeneca...

FDA Must Meet Internal Timelines: Ex-Inspector

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Former FDA inspector Patrick Stone says the agency should adhere to internal timelines for completing inspections and issuing Warn...