Priority Review

Some articles on priority review, review, reviews, priority:

Priority Review Voucher - Limitations
... Fifth, priority review might not be safe ... Priority review should not, however, be confused with accelerated approval or fast track ... Priority review does not omit safety or efficacy studies or require approval within a given time frame ...
Priority Review Voucher - Priority Review
... Prior to approval, each drug marketed in the United States must go through a detailed FDA review process ... FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review ... Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies ...
Priority Review Voucher - The Mechanism
... The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a ... and can be sold, entitles the bearer to a priority review for another product ... Drug User Fee Act targets, the FDA aims to complete and act upon reviews of priority drugs within six months instead of the standard ten-month review period ...

Famous quotes containing the words review and/or priority:

    Americans have internalized the value that mothers of young children should be mothers first and foremost, and not paid workers. The result is that a substantial amount of confusion, ambivalence, guilt, and anxiety is experienced by working mothers. Our cultural expectations of mother and realities of female participation in the labor force are directly contradictory.
    Ruth E. Zambrana, U.S. researcher, M. Hurst, and R.L. Hite. “The Working Mother in Contemporary Perspectives: A Review of Literature,” Pediatrics (December 1979)

    Weekend planning is a prime time to apply the Deathbed Priority Test: On your deathbed, will you wish you’d spent more prime weekend hours grocery shopping or walking in the woods with your kids?
    Louise Lague (20th century)