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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...

FDA Actions Led to Avastin Compounding Ban

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Genentech says FDA concerns caused it to decide not to continue supplying Avastin to compounding pharmacies.

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Federal Register Notice: FDA releases a draft guidance on developing drugs for acute bacterial sinusitis.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

FDA Approvable Letter on Mucinex with Codeine

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FDA sends Adams Respiratory Therapeutics an approvable letter on its NDA for Mucinex with codeine, which is indicated for treating...

First Xenotransplantation Device Approved

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FDA approves a Genzyme humanitarian device exemption application for Epicel (cultured epidermal autografts), indicated for treatin...

FDA Requires New Certification for Petitions

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FDA begins turning away citizen petitions that do not include an FDA Amendments Act mandated certification for those seeking poten...