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Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
Manufacturers of new drugs and biologics, generics and biosimilars, as well as outsourcing facilities, will pay higher user fees for their applications starting Oct. 1, according to figures released Friday by the FDA. Read More
Baxter International is recalling one lot of IV solution over leakage, particulates and missing port protectors — the company’s eighth recall since December 2013 and the second in July. Read More