Cut the tape

Published: Friday 15 December 1995

BIOTECH firms'in the us are elated about a new government cliktat that would help them deal with the Food and Drug Administration's bureaucratic machinery faster than before. Once the rules are implemented, biotech companies will no longer have to file separate applications for new drugs and for the manufacturing facilities that will produce them. Instead, they will have a single license as in the case of regular drugs. Biotech manufacturers no longer need to seek approval for each lot of drugs shipped.

The regulations imposed on biotech firms have historically been much tougher than those on regular pharmaceuticals. Some of the rules date from the turn of the century when it was harder to ensure the consistency and safety of medications drawn from horse blood or urine.

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