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May 04, 2020
Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.
April 22, 2020
With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
April 13, 2020
Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.
March 30, 2020
The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.
March 20, 2020
FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.
February 19, 2020
US and European regulatory officials continue to anticipate supply shortages in multiple areas.
February 06, 2020
The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.
February 05, 2020
The FDA Commissioner plans to address drug prices, the drug approval process, and supply chain issues during his time as commissioner of FDA.
January 14, 2020
Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
January 13, 2020
Can a commitment to limit prices to ensure patient access to important new medicines regain public trust and confidence in the biopharmaceutical industry?