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FDA OKs Remicade for Pediatric Ulcerative Colitis

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FDA approves an expanded indication for Janssen Biotech''s Remicade (infliximab) for treating moderately to severely active ulcera...

Attorney Sees Continuing Off-label Marketing Confusion

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Attorney John Fleder highlights continuing confusion that exists over FDAs position on off-label drug promotion.

Risk Signals Found in 10 Drugs in 2nd Quarter

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FDA says that in the second quarter of 2011 it identified potential safety signals in 10 drugs.

Preemption Law, Applications Reviewed

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Attorney Arnie Friede says FDA and the courts have made differing interpretations of federal preemption law depending on the drug,...

FDA Clears Iris 510(k) Prognostic Prostate Cancer Test

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FDA clears an Iris International 510(k) for its NADiA ProsVue prognostic cancer test for identifying patients at reduced risk for ...

FDA Places Partial Hold on Immunomedics Trial

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FDA places a partial clinical hold on Immunomedics Phase 2B/2 clivatuzumab tetraxetan trial for pancreatic cancer.

FDA Says CFC Inhalers Out by 12/31

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FDA cautions that Primatene Mist will no longer be available as an OTC epinephrine inhaler after 12/31.

VA Dropping Avastin for Eye Disease

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The VA says it will no longer use Avastin to treat wet age-related macular degeneration.

CDRH Seeks to Reshape Compliance Focus Under New Initiative

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CDRH Office of Compliance director Steve Silverman leads an initiative to reshape the medical device industry's compliance focus t...

FDA Clears Verax Test as Safety Measure for Apheresis Platelets

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FDA clears Verax Biomedicals Verax Platelet PGD test as a safety measure for leukoreduced apheresis platelets.