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Mr. Levinson's report said the F.D.A. rejected 96percentt of generic drug applications, and he suggested that the agency should give applicants better guidance about approval standards.
The F.D.A. aims to complete its review of drug applications in 10 months.
It has held drug toxicity workshops for staff members who review new drug applications.
He then spent several years working for the Food and Drug Administration, reviewing new drug applications.
Only a tiny fraction of generic drug applications raise any patent issues, he said.
The F.D.A. said its policy was not to comment on meetings involving particular drug applications.
He would then close out his positions after the F.D.A. released its verdict on drug applications.
Generic drug applications have grown far faster than the budget of the review division for the drugs.
The agency is unable to confirm or comment on any current or pending investigation into new drug applications.
The Senate health committee yesterday unanimously approved a bill that would also limit regulatory delays of generic drug applications.
The industry recently agreed to provide the F.D.A. with nearly $300 million annually to bolster inspections and speed drug applications.
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CEO of Professional Science Editing for Scientists @ prosciediting.com