Druggmpreport

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February 2019

No. 319

Headlines

Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

CDER Features Valsartan in Report on Drug Safety Priorities

CDER released its latest annual report on drug safety priorities, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis. Read More

Shutdown That Curtailed Some FDA Inspections Ends – For Now

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. Read More

FDA Shares New Findings in Valsartan Investigation

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. Read More

FDA Issues New Guidance on Assessing REMS

The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Read More

FDA Denies Petition to Add Warning to Blood Thinner Labeling

The FDA has denied a petition from Public Citizen to add a boxed warning to the labeling for the blood thinner clopidogrel. Read More

FDA Warns Akorn Over Conditions at Sterile Drug Facility

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. Read More

FDA Warns Chinese OTC Drugmaker

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. Read More

483 Roundup: FDA Flags Seven Firms for Testing, Other Issues

The FDA cited seven drug manufacturers for significant problems identified during inspections, ranging from inadequate testing to a failure to secure analytical equipment. Read More

FDA Releases Naloxone Drug Facts Labels to Spur OTC Development

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. Read More

Italian Agency Hits Chinese Heparin Manufacturer for GMP Violations

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 heparin sodium to the EU. Read More

EMA Considers Electronic Product Information Standard for Drugs

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. Read More