Renewed Political Pressure on Hydroxychloroquine for COVID Highlights Need For Independent US FDA
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.
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Former Official Petitions US FDA To Stop Reviewing Russian Firms' Applications Amid Ukraine Invasion
Request from Tim Coté, former Office of Orphan Products Development director, could drag agency back into a political arena it's been trying to avoid. Coté, now consulting through Only Orphans Coté, filed a citizen petition asking agency to “completely freeze all administrative actions on any regulatory requests,” from drug and device companies headquartered in Russia or with majority Russian ownership.
Ex-US FDA Official Petitions Agency To Stop Reviewing Applications From Russian Companies Amid War In Ukraine
The request could drag the agency back into a political arena it has been trying to avoid.
The New Drug Review Program is seeking a contractor to survey employees on the impact of team culture on performance and overall effectiveness.