ARTHRITIS DRUG SIGNS & SYMPTOMS STUDIES SHOULD LAST SIX MONTHS, PHYSICAL FUNCTION STUDIES TWO YEARS -- FDA CMTE.; NSAIDS MAY ADD JRA CLAIM IMMEDIATELY
Rheumatoid arthritis drugs should be studied for a minimum of six months to get a claim for reduction in signs and symptoms of RA, FDA's Arthritis Drugs Advisory Committee recommended Feb. 5. FDA's draft "Guidance for Industry Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis" had proposed a minimum duration of three months for drugs and six months for biologicals ("The Pink Sheet" Jan. 27, T&G-9).
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