CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in Oct. 30 remarks to…

The FDA cited an Eli Lilly facility in Puerto Rico, an Aurobindo plant in southern India and five other facilities for a wide range of GMP and other violations observed…

The FDA issued recent warning letters to manufacturing facilities in India, South Korea, China and the U.S., for a wide range of deficiencies, including inadequate testing. Source: Drug GMP Report

The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs). Source: Drug GMP…

A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force. Source: Drug GMP…

Five drugmakers were cited in FDA inspections for violations that ranged from inadequate smoke studies to a “cascade of failure” at one facility. Source: Drug GMP Report

The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Galt Pharmaceuticals for sending an email to doctors about its insomnia pill Doral (quazepam) that left out…

The FDA has reopened the submission period for its quality metrics feedback program, giving potential participants more time to sign up. Source: Drug GMP Report

Novartis subsidiary AveXis placed the blame for data manipulation over its $2 million spinal muscular atrophy drug Zolgensma squarely on two former senior executives, in a lengthy response to the…

The FDA hit three overseas drugmakers for violations at their facilities that included testing deficiencies, a lack of cleaning validation and other slipups. Source: Drug GMP Report