The crisis of nitrosamine contamination in prescription drug products continues to roil the world’s health authorities and prompts debate on the different approaches used to measure these impurities. Meanwhile, an Austrian firm gets inspected despite the pandemic and yet another homeopathic firm gets an FDA warning letter.
The discovery of nitrosamine contamination in prescription drugs continued to command regulatory attention in recent weeks.
It prompted the US Food and Drug Administration to explain why it tested and found nitrosamine impurities at lower levels...
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The compounding industry said the FDA’s “green list” of GLP-1 API imports for compounded drugs validates legitimate compounding pharmacies’ role in the US health system.
Pharmaceutical manufacturers encouraged the FDA to consider including expansions and modifications of existing US drug facilities in the PreCheck program.
The EU is diversifying its trading partners, which means that new markets may open up to the pharmaceutical industry, countering transatlantic tensions.
The clarity on quality topics provided by the CMC Readiness Pilot (CDRP) is worth the work of preparing a comprehensive development review and multiple meetings, participants from Intellia, Bicycle Therapeutics and Bristol Myers Squibb said during a Duke Margolis meeting.
The compounding industry said the FDA’s “green list” of GLP-1 API imports for compounded drugs validates legitimate compounding pharmacies’ role in the US health system.
Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.
The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.
