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The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product. Read More
Drugmaker and pharmacist groups called on the FDA to amend its draft guidance on supply chain verification systems, saying the draft doesn’t account for the varying conditions at facilities. Read More
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. Read More
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. Read More
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. Read More
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Read More
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
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
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