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companies from even convening focus groups to determine how to make packaging and labeling more user-friendly); and new controls over manufacturing that can cause interruptions in drug production during clinical trials for even the most trivial change in procedure.

As a result, the number of applications submitted to the FDA for marketing approval, in particular of biologies, has declined: during FDA fiscal year 1993, ten were submitted, compared to eight in FY 1994. The absolute number of products approved is declining as well. According to the Pharmaceutical Research and Manufacturers of America, in 1994 the FDA approved 22 drugs, down from 25 in 1993. In short, products are being further slowed in an already sluggish testing pipeline. Bear in mind that these products could help

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companies from even convening focus groups to determine how to make packaging and labeling more user-friendly); and new controls over manufacturing that can cause interruptions in drug production during clinical trials for even the most trivial change in procedure.

As a result, the number of applications submitted to the FDA for marketing approval, in particular of biologies, has declined: during FDA fiscal year 1993, ten were submitted, compared to eight in FY 1994. The absolute number of products approved is declining as well. According to the Pharmaceutical Research and Manufacturers of America, in 1994 the FDA approved 22 drugs, down from 25 in 1993. In short, products are being further slowed in an already sluggish testing pipeline. Bear in mind that these products could help