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
The FDA announced that the impurities found in valsartan-containing blood pressure drugs may have been caused by specific chemicals and reaction conditions in the manufacturing process of the drug’s API.…
The FDA reopened on January 25 following a 35-day partial shutdown of the federal government that curtailed the agency’s inspection activities that did not directly tie into public safety. Source:…
The FDA hit Hangzhou Guogang Touring Commodity, an OTC drug manufacturer in Zhejiang, China, with a warning letter, for significant problems with equipment cleaning and drug product conformity. Source: Drug…
The FDA issued revised guidance on electronic submissions of drug master files, extending the timetable for Type III submissions by another year to May 5, 2020. Source: Drug Industry Daily