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Abbott Files sBLA for Humira in Crohns

[ Price : $8.95]

Abbott Laboratories submits a supplemental BLA seeking an expanded indication for Humira as a treatment for moderate-to-severe Cro...

MAPP Out for Good Review Practices

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CDER publishes a policy and procedures manual section on developing and using good review practices in product reviews.

Group Clears Merck Management Over Vioxx

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An independent investigation finds Merck management activities involving Vioxx reflected poor judgment and errors but no intent to...

FDA Panel Backs Fragmin Expanded Use

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FDAs Oncologic Drugs Advisory Committee recommends approval for an expanded indication for Pfizers Fragmin treating cancer patien...

Problems at MDS Pharmas Bioanalytical Facility Drag On

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MDS Pharma says FDA-related problems continue to linger at the troubled contract research organizations St. Laurent, Canada bioana...

FDA OKs Watsons Generic Seasonale

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FDA approves a Watson Pharmaceuticals ANDA for a generic copy of Durameds Seasonale contraceptive.

100 Million Flu Vaccine Doses Available

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CDC says FDA has helped manufacturers prepare to ship a record volume of flu vaccine this season.

Taxus Stent Has Higher Blood Clot Risk

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Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis with its Taxus drug-eluting sten...

ASRs Guidance Answers FAQs

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Federal Register Notice: FDA releases a draft guidance on frequently asked questions about commercially distributed analyte specif...

Guidance on IVD Multivariate Index Assays

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Federal Register Notice: FDA releases a draft guidance on in vitro diagnostic mulivariate index assays.