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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COVID-19 Therapeutics: US FDA Wants Sponsors To Use The Pre-IND Route, Not The Pre-EUA Path
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.
Building A Bridge To A COVID-19 Vaccine: Hydroxychloroquine And BCG Lead Prevention Pipeline
More than 40 Phase III trials are assessing pre- and post-exposure prophylaxis of SARS-CoV-2 infection.