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PDUFA e-Submission and Data Standards Public Meeting

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Federal Register notice: FDA announces a 3/21/2018 public meeting on Prescription Drug User Fee Act of 2017; Electronic Submission...

Reviewers Cite Rhopressa Efficacy

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FDA medical reviewers say Aeries Rhopressa is effective in lowering eye pressure in some patients.

FDA Denies Without Comment AZ Falsodex Petition

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FDA denies an AstraZeneca petition asking that the agency rule on specific aspects of a 505(b)(2) NDA referencing Falsodex IM inje...

Drug Safety Data Threat Growing: PwC Report

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The PriceWaterhouseCoopers Health Research Institute says that drug companies face a growing threat from FDA changes to the collec...

PDUFA 6 User Fees Explained

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FDA issues a draft guidance explaining the user fee structures and types of fees under the PDUFA 6 reauthorization.

Draft Abbreviated Approval Pathway Guidance

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FDA publishes a draft guidance to help sponsors choose the appropriate abbreviated approval pathway and understand what data and i...

Merck Scraps NDA Filing for Cholesterol Drug

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Merck says it will not seek FDA regulatory approval for anacetrapib, an investigational cholesteryl ester transfer protein inhibit...

Guidance on GDUFA Division Reconsideration Requests

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FDA releases a draft guidance on the procedures for ANDA applicants to resolve scientific or regulatory disputes with FDA at the a...

Baxter Importing IV Drugs from Ireland

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FDA says it is working with Baxter Healthcare to temporarily import some IV products manufactured at Baxters plant in Ireland to a...

Draft REMS Document Format Guidance Out

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FDA publishes a draft guidance on the content and format of REMS documents, revising a 2009 draft guidance.