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FDA Seeks To Hasten Review of Biotech Drugs (Saturday, Sept. 7, 2002 -- CropChoice news) --
The Washington Post, 09/07/02: Some new drugs developed through
biotechnology will be approved in the future
by the Food and Drug Administration's drug
evaluation center rather than its biologics
center, the agency announced yesterday.
Many biotechnology companies have
recommended the shift, saying the agency's
drug evaluation center is better staffed and
can review the applications more swiftly.
FDA officials said the move makes sense
because the testing, evaluation and use of the
pharmaceuticals is similar, whether the drugs
are created through traditional chemical
means or through newer biotechnology.
While the Center for Biologics Evaluation
and Research will lose its review authority
over the drugs created through biotechnology,
it will maintain control over vaccines, blood
safety, gene therapy and tissue
transplantation.
In recent years, the Center for Drug
Evaluation and Research has gained in
industry respect because of its relative speed
in reviewing applications. It was the first
center at the FDA to be given additional staff
and funds through the user fees that drug
companies have paid since 1994 when they
apply for approval to sell their products. The
biologics center will not begin receiving
user-fee funds until next year.
Carl Feldbaum, president of the
Biotechnology Industry Organization, said
his group welcomed the change, which he
said reflected concerns that were raised when
the user-fee legislation was reauthorized over
the summer.
"The industry has been impressed with [the
drug center's] close attention to review time
clocks," he said, adding that the biologics
center did not have as good a record... http://www.washingtonpost.com/wp-dyn/articles/A48047-2002Sep6.html | |
