Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Source: Drug…
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Source: Drug GMP Report
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to…
The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and the lack of procedures for drug distribution at its Aventura, Florida facility. Source: Drug GMP Report
Rep. Frank Pallone (D-N.J.) proposed new legislation on continuous manufacturing during a joint visit with FDA Commissioner Scott Gottlieb to Rutgers University to discuss the campus’ role in advancing the…
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Source: Drug…
The FDA cited five drugmakers for problems relating to training, unsanitary conditions, document handling and other deficiencies. Source: Drug GMP Report
The FDA issued warnings to three overseas and two U.S. facilities for a variety of nonconformances including inadequate testing. Source: Drug GMP Report
The House passed an omnibus spending bill on March 22 that boosts FDA funding for medical product safety activities by $113.2 million, including a one-time payment of $94 million to…
Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Source:…