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Needless Fear Makes Drug Firms Shun Dispute Resolution: Jenkins

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CDER Office of New Drugs director John Jenkins tells RAPS that drug sponsors still dont use the dispute resolution process as much...

Drug Safety Alerts the Norm Despite Labeling Talks: Seligman

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CDER safety policy and communication associate director Paul Seligman says the Center will continue releasing emerging drug safety...

Faster FDA Reviews for Priority Generics

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CDER director Steven Galson announces a new policy for expediting reviews of generic products that meet certain priority criteria....

New Indication for Taxotere

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FDA approves using Taxotere with cisplatin and fluorouracil for treating head and neck squamous cell carcinoma.

18 Drug Companies in Top 200 Brands

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Ad Age says 18 drug companies placed in the Top 200 advertisers for the first half of 2006 based on their ad spending.

FDA Moving Ahead with Unique Device Identifier

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CDRH director Dan Schultz tells RAPS the agency intends to establish a unique device identifier system for medical devices to redu...

Measuring Compliance: Issue Shows Need for FDA Lab

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Consulting editor John Scharmann follows up on responses to his article of measuring compliance, observing that the situation warr...

Terrorism Duties Take More CBER Reviewers

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CBER director Jesse Goodman says current concerns over terrorism, including bioterrorism, are increasingly occupying the Centers r...

CDERs Jenkins Says Honesty is Most Important in NDAs

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Asked to provide his best advice for industry in their dealings with the agency, CDER Office of New Drugs director says be honest ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Qiagen and Randall K. Wolf.