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sNDA Submitted for Aloxi Oral Formulation

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MGI Pharma and Helsinn Healthcare submit a supplemental NDA for an oral capsule formulation of injectable nausea drug Aloxi.

FDA Guide on HIV Resistance Testing

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FDA says it wants more HIV resistance testing during antiretroviral drug development and post-marketing periods.

State Law Stops Access to Health Info: WLF

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Washington Legal Foundation calls on a federal appeals court to uphold a lower court ruling against a New Hampshire law banning co...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites CoLigne, GE Infrastructure, Heartland Products, and Sanofi-Aventis.

FDA Tentatively OKs Barrs Generic Mirapex

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FDA tentatively approves a Barr Laboratories ANDA for a generic copy of Boehringer Ingelheim Pharmaceuticals Mirapex.

Sinusitis Drug Guidance Available

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Federal Register Notice: FDA releases a draft guidance on developing drugs for acute bacterial sinusitis.

ORA Reorganization is Dead

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Consulting editor John Scharmann reports that the much-criticized Office of Regulatory Affairs reorganization plan is dead, due to...

Supplement Manufacturer Warned

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FDA says Health Freedom Nutritions labeling and promotional claims for many products make them unapproved new drugs.

Firm Wins Contract to Digitize FDA Inspection Docs

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FDA awards Quality Associates a five-year, $20 million contract to digitize, index and consolidate 20 million pages of FDA inspect...

Michigan Dems Want to Limit Doctor Gifts

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Michigan legislators consider a bill to limit the value of gifts drug companies can give doctors and to require disclosure of comp...