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FDA Sends Collection of Info on Device Tracking to OMB

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Federal Register Notice: FDA submits a proposed collection of information on medical device tracking to the Office of Management a...

FDA Panel Votes to Retain Chantix Boxed Warning

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A joint FDA advisory committee votes to recommend retaining a boxed warning on Pfizers smoking cessation drug Chantix (varenicline...

CDER Revamp Includes Office of Pharmaceutical Quality

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CDER director Janet Woodcock announces a 1/5/15 Center reorganization that includes creation of a super-office Office of Pharmaceu...

High Court Mixed on Changing Federal Circuits Role in Patent Appeals

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The U.S. Supreme Court expresses mixed reactions to whether the Federal Circuit Court of Appeals should continue to be given leewa...

County Health System Wants Clozapine REMS Changed

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Michigans Genesee County Health System asks FDA to revise the clozapine REMS so the drug can be used in African-American patients ...

Court Says Branded Drug Design Defects Preempted

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An Ohio federal judge says that Johnson & Johnson could not comply with a Georgia law requirement to change the composition of its...

Orphan Drug Status for OctreoPharm Tumor Drug

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FDA grants OctreoPharm Sciences an orphan drug designation for its new radiotracer OPS202, indicated for managing neuroendocrine t...

FDA Refuse-to-File Letter for Insys Dronabinol

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FDA issues Insys Therapeutics a Refuse-to-File letter for its proprietary dronabinol oral solution because it provided an inadequa...

Guidance on New Chemical Entity Exclusivity on Fixed-Combo Drugs

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Federal Register Notice: FDA releases a new guidance: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination...

Canadian Web Site Selling Unapproved HIV Tests

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CBER says a Canadian Web site is illegally promoting unapproved at-home HIV tests for sale in the U.S.