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FDA, U.S. Army Sign Infection Emergency MOU

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Federal Register Notice: FDA provides notice of a memorandum of understanding with the U.S. Army Research Institute of Infectious ...

Zineh Named Associate Director of Genomics

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CDER names Issam Zineh the associate director of genomics in CDERs Office of Clinical Pharmacology.

FDA Approves Apridra For Kids

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FDA approves an expanded indication for Sanofi-Aventis Apidra to improve glycemic control in children age 4 and older.

Top FDA Career Staff Objected to Preemption

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Capitol Hill investigators say internal FDA documents demonstrate that senior career officials strenuously opposed efforts led by ...

Obama Change Wont Do Much at FDA

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Washington commentator Robert Steeves reviews the likelihood of significant change at FDA should Barack Obama win the White House ...

ANDA Submissions Drop for First Time in 8 Years

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CDER Office of Generic Drugs director Gary Buehler tells an industry conference that ANDA submissions have declined for the first ...

Comments Sought on Bioequivalence Waivers

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Federal Register Notice: FDA seeks comments on waiver procedures for in vivo demonstration of bioequivalence for soluble powder or...

OMB OKs Supplement Claims Info

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on substantiation for dieta...

FDA Warns Bayer on 2 OTC Aspirin Products

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In a late confrontation with the global giant,FDA warns Bayer over two OTC combination aspirin drugs the company has marketed with...

FDA Approves Hi-Techs Generic Cosopt

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FDA approves a Hi-Tech Pharmacal ANDA for a generic copy of Merck's Cosopt, indicated for reducing elevated intraocular pressure.