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Jury Awards Man $1.1 Million in Levaquin Case

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A federal jury awards a man punitive and compensatory damages from Johnson & Johnson after finding that the company did not proper...

House Backs More Money for FDA

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The Alliance for a Stronger FDA says a House-approved continuing resolution would treat FDA better than many other agencies by giv...

FDA Publishes Advisory Committee Public Comment Guidance

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FDA issues a guidance for people who want to comment during advisory committee sessions.

Teva Plans NDA for Multiple Sclerosis

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Teva Pharmaceutical Industries says it could file an NDA late next year after reporting positive Phase 3 trials involving oral laq...

Review Period Set for Ilaris

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Federal Register Notice: FDA determines the regulatory review period for Novartis Ilaris for the purpose of patent extension.

FDA Sets Bepreve Review Period

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Federal Register Notice: FDA determines the regulatory review period for Ube Industries Bepreve for the purpose of patent extensio...

Sabril Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Lundbeck, Inc.s Sabril for the purpose of patent extensio...

Now McNeil Recalls All Rolaids Lots

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Capping other quality failures this year, McNeil recalls all U.S. lots of three Rolaids products after consumers report finding wo...

Agency Aiming to Ease Burden Caused by REMS: Woodcock

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CDER director Janet Woodcock tells an industry meeting that the agency needs to make the risk evaluation and mitigation strategy (...

White House Panel Urges Faster, Wider Health Data Use

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The Presidents Council of Advisors on Science and Technology urges rapid decisions to establish a universal exchange language for ...