Bowing to President Trump’s latest push to authorize the anti-malarial drug for COVID-19 could damage the reputation of the agency for the duration of the pandemic and beyond, experts say, arguing it may be the best example yet of why the FDA’s decision making needs to be more clearly delineated from the country’s political leadership.
Another push from top US political leaders to use hydroxychloroquine to treat COVID-19 might be the breaking point that finally leads to a US Food and Drug Administration restructuring that insulates it from political pressure.
The situation highlights the nearly impossible situation FDA Commissioner Stephen Hahn faces – either following the science, which experts say points against hydroxychloroquine, or following his boss, President Donald
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
