Continuing Resolution Keeps FDA Funded Through Dec. 20
President Trump has signed without fanfare a continuing budget resolution that will keep the FDA funded at the 2019 level until Dec. 20. Source: Drug Industry Daily
FDA Cites Two Aurobindo Facilities for Serious GMP Violations
The FDA hit two Aurobindo facilities for serious violations of good manufacturing practices discovered during inspections in October. Source: Drug Industry Daily
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…
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…
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. Source: Drug GMP Report
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The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs). Source: Drug GMP…
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. Source: Drug GMP…
FDA Plans to Exempt Five Class II Devices From Premarket Notification
The FDA is proposing to exempt additional Class II medical devices from 510(k) premarket notification requirements. Source: The GMP Letter
CDRH Releases Guidance Priorities for Fiscal 2020
CDRH released a list of priority guidances it plans to publish during fiscal 2020, including numerous quality-related final and draft guidances. Source: The GMP Letter
483 Roundup: Six Firms Cited for Quality, Other Compliance Failures
The FDA hit six devicemakers for a range of compliance failures observed during facility inspections, including lax acceptance procedures and missing records. Source: The GMP Letter
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