NDA reviews could not be delayed due to integrity issues under PhRMA FDA reform bill.
This article was originally published in The Tan Sheet
Executive Summary
NDA REVIEWS COULD NOT BE DELAYED DUE TO DATA INTEGRITY ISSUES UNDER PhRMA's PROPOSAL on FDA reform. According to reform legislation drafted by the Pharmaceutical Research & Manufacturers of America, "no action by" FDA on "any matter relating to a new drug or a biologic may at any time or under any circumstance be delayed because...of issues relating to the integrity of data, except on the basis of evidence presented to the applicant, followed by an informal hearing, that data in that particular application are false." FDA's current practice is to suspend review of all applications from a sponsor when questions are raised about data integrity in any application.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning