Anaxagoras - more fresh air - from the FDA website
WIth the new PDUFA (Prescription Drug User Fee Act) program ALREADY IN PLACE at the FDA, Vasomax can be approved in as little as 10 MONTHS - under standard review.
The following is excerpted from the FDA's website...
hhs.gov
It is taken from FDA testimony before the House Appropriations committee on 2/25/98. The section it appears in is titled "Pharmaceuticals and Biologicals"
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Last year, FDA received a record number of new drugs and biologics for review and the Agency approved a record number of them, 144. Among these were 62 new molecular entities or NMEs, a record number of these important new products, which went on the market for the first time in this country. NMEs often represent hope for patients by providing new treatments or by providing significant improvements over existing therapies, either through heightened effectiveness or reduced side-effects.
And the Agency has done all this even as it reduced the time it takes - on average - to get a drug through review and onto the market from 14.8 months in calendar year (CY) 96 to 12.2 months in CY 97. That's for all types of drugs, both priority drugs and standard drugs. FDA has met the agreed to deadlines negotiated by the Agency, Congress and the industry. For the last two years, we have approached or hit 100 percent on-time performance.
With the renewal of the Prescription Drug User Fee Act last year, FDA will increase the number of reviewers and support staff under this program to 820 in FY 99, ensuring that the Agency will be able to continue to perform at its current high level.
The evidence of PDUFA's success comes not only from the performance statistics, but also from the strong support FDA received from industry for its renewal, as well as the prestigious Innovations in Government Award given for the improvements in the drug and biologics approval process. The award is sponsored by the Ford Foundation, Harvard University's John F. Kennedy School of Government in partnership with the Council in Excellence in Government
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Under the PDUFA renewal, FDA has promised to improve its drug-review performance still more. Under the previous version of the program, FDA had 12 months to review a standard drug and six months to review priority drugs. We have been meeting those deadlines. Under the new program, FDA will gradually ratchet down approval times for standard drugs by an additional two months.
In addition to requesting the increased resources authorized in FY 99, the President's budget also requests supplemental appropriations for FY 98 of $26 million in additional revenue for the Agency to begin, in earnest, the enhancements envisioned in the reauthorization of PDUFA. With the resources provided by this renewal, FDA expects to continue its high level of performance and provide American patients with speedy access to drugs and biologics while maintaining the Agency's customarily high scientific standards.
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Brings the possibility of real revenues in by a year or so - unless the FDA is lying to Congress. |
