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FDA Stops Montana Couple Making Illegal Drugs

[ Price : $8.95]

FDA signs a consent decree with a Montana couple and their company prohibiting them from manufacturing unapproved new drugs and ad...

FDA Clears Bio-Rad Labs Test for Rheumatoid Arthritis

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FDA clears Bio-Rad Laboratories 2200 Anti-CCP test for early detection of rheumatoid arthritis.

Pharmalink Gets Orphan Drug for Renal Disease Drug

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FDA grants Pharmalink AB orphan drug status for its Nefecon for patients with IgA nephropathy or Bergers disease.

FDA Funds Childhood Cancer Trial

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An FDA grant supports a childhood cancer clinical trial at Cincinnati Childrens Hospital Medical Center.

FDA OKs P&U sNADA for Swine Respiratory Disease

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Federal Register Final rule: FDA approves Pharmacia & Upjohns supplemental NADA for using ceftiofur crystalline free acid suspensi...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Natures Health Company, Thomas OBarr Jr., Rx-Drugs.com, and Lamar L. Snow.

Roche Reports Positive Avastin Trial Results for New Indication

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Roche says new trial results support continuing Avastin development for ovarian and breast cancer indications.

Court Allows Teva Aricept Patent Challenges

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A federal appeals court allows Teva to challenge four Eisai Aricept patents.

FDA Says Firm Sells Unapproved Drugs on 294 Web Sites

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FDA says an Internet marketer is using 294 Web sites to sell unapproved and misbranded drugs.

Who Can Explain Regulatory Science?

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FDA Matters editor Steven Grossman says FDAs off-base definition of regulatory science is likely to lead to the initiative being i...