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FTC Should Block Pfizer/Mylan Merger: Public Citizen

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Public Citizen calls on the FTC to block the proposed merger of Pfizers Upjohn unit with Mylan.

FDA Sets FY 2020 Outsourcing Facility User Fee Rates

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Federal Register notice: FDA announces fiscal year 2020 rates for the establishment and re-inspection fees related to drug compoun...

CDER NextGen Portal to Take Number Requests

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CDER says its NextGen Portal can receive pre-assigned NDA, IND, BLA, and DMF number requests starting 8/19.

House Committee Asks FDA Heparin Briefing

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Leaders of the House Energy and Commerce Committee ask FDA for a briefing on the potential for a shortage of heparin in the U.S. d...

Sunovion NDA for Binge Eating Disorder Submitted

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FDA accepts for review a Sunovion Pharmaceuticals NDA for dasotraline for treating patients with moderate-to-severe binge eating d...

Zeus Scientific New Indication for 4 Lyme Disease Tests

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FDA clears 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease.

Comments Sought on Drug Compounding Research

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Federal Register notice: FDA seeks comments on a new information collection entitled Obtaining Information To Understand Challenge...

Guide on Kidney Transplant Delayed Graft Function

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FDA posts a guidance entitled Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.

FDA Gives Orchard Advanced Status for Gene Therapy

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FDA grants Orchard Therapeutics a Regenerative Medicine Advanced Therapy designation for the companys ex vivo autologous hematopoi...

First Pharma Cited for GMPs on Form 483

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FDA posts a Form 483 after inspecting First Pharma Associates in Spokane, WA last month.