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Manufacturing

Set Alert for Manufacturing

Coronavirus May Boost Policy Efforts To Enhance US Drug, Medical Supply Production

Sen. Alexander says Congress should consider options to alleviate US dependence on other countries for drug and medical supply production once the outbreak subsides.

Manufacturing Infectious Diseases Legislation

Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

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.

Manufacturing Quality BioPharmaceutical

Latest From Manufacturing

UK MHRA Relaxes GMP Rules For Drugs Imported From Third Countries During COVID-19 Outbreak

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.

Quality United Kingdom

Gottlieb’s Rx For Coronavirus

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.

Coronavirus COVID-19 Clinical Trials

US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand

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.

BioPharmaceutical Manufacturing

Quality Experts Advise Industry To Move Products To Local Sites In Responding To COVID-19

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.

Manufacturing Quality

More Time For EU Nitrosamine Evaluations Due To COVID-19

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

Coronavirus COVID-19 Manufacturing

UK Attacks Pandemic With Funding For Drug And Vaccine Trials

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.

United Kingdom Coronavirus COVID-19
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