The FDA issued final guidance for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Source: Drug GMP Report
The FDA issued Form 483s to five foreign manufacturers, citing a variety of quality concerns. Source: Drug GMP Report
The FDA released a trio of guidances on Drug Supply Chain and Security Act (DSCSA) requirements for drugmakers to attach identifiers to their prescription drugs. Source: Drug GMP Report
The FDA warned four drug manufacturers over a variety of procedural shortcomings, including ones for process control and sterility. Source: Drug GMP Report
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The FDA cited New Taipei City manufacturer Delta Synthetic for its methods of sanitizing the facility’s water system. Source: Drug Industry Daily
A Delaware court on Monday sided with Fresenius in its bid to pull out of a planned $4.3 billion merger with Akorn because of alleged fraud and falsified testing data…
Brand name prescription drug prices increased four times faster than inflation last year, according to AARP’s latest drug pricing report. Source: Drug Industry Daily
A provision in the proposed U.S.-Mexico-Canada Agreement that would give branded biologics makers a decade of exclusivity goes against the White House’s stated priority of improving access to biosimilars, according…
The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert Friday and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood…