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Waxman Introduces Generic Biologics Bill

[ Price : $8.95]

U.S. Representative Henry Waxman (D-CA) introduces a bill to allow FDAs approval of generic biologics.

Lilly Evaluating Arxxant Options

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Lilly says it is considering development options for its Arxxant, indicated for treating diabetic retinopathy, after FDA said anot...

Transparent Drug Safety Summaries Coming Fast: FDA

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CDER revamps its Drug Safety Oversight Board public summaries to meet the long-neglected demands of greater transparency.

Tennis Star in GSK Asthma Campaign

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Tennis star Mary Joe Fernandez urges Hispanic-Americans with asthma to take the Asthma Control Test.

FDA Guide on Quality System/GMP Correlation

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A new FDA guidance describes a comprehensive quality systems model for use by drug and biologic manufacturers to support and susta...

OGD Gives Abilify Study Guide

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OGD provides recommendations for bioequivalence testing for aripiprazole ANDA applicants.

Pharma Congress Features FDAs Blumberg, Other Regulators

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This years Pharmaceutical and Regulatory Compliance Congress features a regulators roundtable with FDA deputy chief counsel Eric M...

Guidance on Starting Materials for Viral Vaccines

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Federal Register Notice: FDA releases a draft guidance on characterization of cell substrates and other biologic materials used to...

Review Period Set for Lyrica

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Federal Register Notice: FDA determines the regulatory review period for Warner-Lamberts Lyrica.

Review Period Set for Plenaxis

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Federal Register Notice: FDA determines the regulatory review period for Praecis Pharmaceuticals Plenaxis is 2,566 days.