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WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.
The Generic Pharmaceutical Association heralded the news Thursday. "Making these hiring decisions is an important step to achieve the goal of [the Generic Drug User Fee Amendments] and address the delays that reduce Americans' access to affordable medicines," GPhA president and CEO Ralph Neas said. "The FDA has a critical task at hand: reducing the backlog in applications for new generic medicines and speeding the average [abbreviated new drug application] approval time."
As DSN reported Wednesday, FDA Center for Drug Evaluation and Research director Janet Woodcock sent a memo to employees announcing that the agency had hired 234 people as part of its GDUFA Human Capital Team, in excess of the 231 it had intended to hire.