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Quarterback in Drug Company Funded Crohns Program

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Centocor Ortho Biotech pledges to donate $10,000 to Crohns disease programs as part of pro quarterback David Garrards Zone for Cro...

FDA Lifts Clinical Hold on Hepatitis B Vaccine

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FDA removes a clinical hold on Dynavax Technologies IND for its Heplisav hepatitis B vaccine and a trial in individuals with chron...

FDA OKs Wilmington NDA for GERD Drug

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FDA approves a Wilmington Pharmaceuticals NDA for Metozolv ODT (metoclopramide HCl), an orally disintegrating drug for treating ga...

Dey Reports Albuterol Sulfate Theft

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Dey says that 35,760 cartons of unit-dose vials of albuterol sulfate inhalation solution were stolen from a tractor-trailer in Tex...

Harkin Takes Over Senate HELP Committee

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Sen. Tom Harkin (D-IA) agrees to take over the late Sen. Edward Kennedys (D-MA) chairman seat on the Health, Education, Labor and ...

Care-Tech Decree Signed

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FDA says that Care-Tech Laboratories and its principal owners have signed a consent decree barring them from manufacturing and sel...

Reckitt Benckiser Amends Suboxone Petition

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Rekitt Banckiser asks FDA to rule that generic forms of Subutex and Suboxone must comply with impurity levels in the two drugs NDA...

FDA Says Some Generic Testosterone Products Need Studies

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FDA says it agrees with Auxilium Pharmaceuticals that a number of studies should be required for generic applications for testoste...

ChemGenex NDA Submitted on Leukemia Therapy

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ChemGenex Pharmaceuticals submits an NDA for Omapro (omacetaxine mepesuccinate), indicated for treating patients with chronic myel...

Comments Sought on Environmental Impact Info

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Federal Register Notice: FDA seeks comments on reporting requirements contained in the FDA regulation Environmental Impact Conside...