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
FDA Commissioner Scott Gottlieb said that the agency is ramping up its efforts to improve public warnings and recall notifications. Source: Drug GMP Report
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.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
The European Medicines Agency began a six-month public consultation Thursday for draft principles on a common EU standard for human drug electronic product information. Source: Drug GMP Report
FDA Commissioner Scott Gottlieb announced that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone.…
The Italian Medicines Agency found serious GMP violations during an Oct. 31 inspection of a heparin manufacturing facility in China and recommended that the firm be prohibited from supplying crude…
The FDA cited seven drug manufacturers for significant problems identified during inspections, ranging from inadequate testing to a failure to secure analytical equipment. Source: Drug GMP Report
The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois on Jan. 4 over poor aseptic conditions observed during an inspection last spring. Source: Drug…
The FDA has denied a petition from Public Citizen to add a boxed warning to the labeling for the blood thinner clopidogrel. Source: Drug GMP Report
The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Source: Drug GMP Report