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Sen. Alexander says Congress should consider options to alleviate US dependence on other countries for drug and medical supply production once the outbreak subsides.
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.
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The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.
Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.
The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.
Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.
Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.
Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.
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