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County Health System Wants Clozapine REMS Changed

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Says Generic BE Not Impacted by Software Concerns

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FDA says that generic bioequivalence determinations are not impacted by recent concerns raised by a scientific article that questi...

Hospira Recalls Several LifeCare Products Due to Leakage

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Hospira recalls certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for l...

ADR Network Wants Levaquin Psychiatric Labeling Info

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The Southern Network on Adverse Reactions asks FDA to require addition of specific psychiatric adverse events to Levaquin labeling...

FDA Approves Expanded Use of Lymphoseek

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FDA approves a Navidea Biopharmaceuticals supplemental NDA for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) inje...