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FDA Accepts Roche MycoTOOL for Biological Product Test

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance, Providing Submissions in Electronic Format Summary Level Clinical Site Da...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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Manufacturing vs. Compounding Line Hard to Draw, FDA Told

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FDA is told by state representatives that the defining differences between compounding and manufacturing remain the major problem ...

FDA Approves Mylans Generic Qualaquin

[ Price : $8.95]

FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Mutual Pharmaceutical Co.s antimalarial Qualaquin.

FDA Accepts Telemonitoring for Lisinopril MS Trial

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FDA approves a Phase 2a IND trial of lisinopril for treating multiple sclerosis using telemonitoring instead of most patient trial...