Archive for March 2019
Gottlieb Updates Lawmakers on Plans to Expand FAERs
FDA Commissioner Scott Gottlieb highlighted the agency’s plans to expand data collection on adverse event reporting in his Feb. 27 testimony before a key House appropriations subcommittee. Source: Drug GMP Report
Read MoreThree Drugmakers Draw FDA Reprimands for Quality Failures
The FDA issued Form 483 reports to a trio of drugmakers for various quality issues observed during inspections. Source: Drug GMP Report
Read MoreFDA Issues Five Warning Letters, Citing CGMP Violations, Insanitary Conditions
The FDA issued a series of warning letters to three foreign and two U.S. drugmakers, faulting them for violations ranging from inadequate aseptic processing areas to use of APIs subject to an import alert. Source: Drug GMP Report
Read MoreFDA Says 505(q) Petitions Pull Resources from Safety Activities
Petitions aimed at delaying approvals of competing drugs are diverting resources away from the agency’s public health efforts, the FDA said in a report to Congress. Source: Drug GMP Report
Read MoreFDA Increases Efforts to Flag Public Warnings, Recalls
FDA Commissioner Scott Gottlieb said that the agency is ramping up its efforts to improve public warnings and recall notifications. Source: Drug GMP Report
Read MoreFDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Source: Drug GMP Report
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