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November 2019

No. 328


Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

Drug Shortage Task Force Finds ‘A Broken Marketplace,’ Say Sharpless, Woodcock

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. Read More

FDA Suggests Alternative NDMA Test for Ranitidine

The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read More

FDA Seeks Feedback on Best Practices for Postmarket Surveillance

The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs).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

Warning Letter Roundup: FDA Warns Six Facilities for GMP, Other Failures

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. Read More

483 Roundup: FDA Hits Seven Firms for GMP, Quality Violations

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 during inspections by agency officials. Read More

Woodcock to Congress: U.S. Must Revamp Manufacturing to Spur APIs

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 a House subcommittee. Read More