US FDA Safety Alert For Hydroxychloroquine Is Latest Turn In Drug's Strange Journey
As potentially life-threatening heart problems emerge in coronavirus patients, FDA says hydroxychloroquine should be taken only in clinical trial or hospital settings under the Emergency Use Authorization.
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Providing information in a pre-IND meeting request will facilitate a more efficient development process, agency says in a new guidance; generally, there is insufficient information to assess if and when an emergency use authorization might be appropriate when a sponsor first enters discussions with the FDA.
Coronavirus Notebook: US FDA Cuts Hotline Hours, Regulatory Relief May Be Permanent, Trump's Hydroxychloroquine Prescription
Dispatches from a world turned upside down include approval of more hydroxychloroquine ANDAs, a window into what post-pandemic regs at the US FDA might look like, and some bad news for night shift works who need coronavirus advice from the agency.
More than 40 Phase III trials are assessing pre- and post-exposure prophylaxis of SARS-CoV-2 infection.