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Execs, Not FDA, to Blame for Innovation Lag: Pundit

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Forbes commentator Bernard Munos says drug companies should fix their own problems with drug innovation rather than blaming FDA.

FDA Urged to Bar Generic Opioids that Can be Abused

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Former FDAer Scott Gottlieb and Sen. Tom Coburn call on FDA to quickly reject generic opioids that are not tamper-resistant.

Amarin Wants Chemport to be Vascepa API Supplier

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Amarin asks FDA to approve Chemport as an additional API supplier for its Vascepa.

FDA Accepts Roche MycoTOOL for Biological Product Test

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FDA accepts Roches MycoTOOL as the first commercially available mycoplasma test for release testing of a biopharmaceutical product...

ViroPharma Opens Phase 2b Study in Hereditary Angioedema

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ViroPharma Inc. initiates a Phase 2b study to evaluate the safety and efficacy of subcutaneous Cinryze in combination with Halozym...

Guidance on E-Submissions for Clinical Site Dataset

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Federal Register Notice: FDA releases a draft guidance, Providing Submissions in Electronic Format Summary Level Clinical Site Da...

FDA Approves sNDA for Rescula in Glaucoma

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FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula ophthalmic solution to allow its use as a first-line therapeut...

Matrixx Recalls 1 Zicam Nasal Gel Lot

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Matrixx Initiatives recalls one lot of Zicam Extreme Congestion Relief nasal gel after finding a small amount of Burkholderia cepa...

Panel to Discuss Drugs Containing Hydrocodone

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Federal Register Notice: FDAs Drug Safety and Risk Management Advisory Committee will meet 1/24-25/13 to discuss drugs containing ...

FDA Holds Hearing on Opioid Drugs

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Federal Register Notice: FDA plans a public hearing 2/7-8 to obtain information on the use of opioid drugs in treating chronic pai...