Postmarket Requirements Will Be "Studies" Unless "Trials" Are Needed - FDA
FDA's 1draft guidance on how it will implement the authority under the FDA Amendments Act to require postmarketing research activities by sponsors defines a difference between "studies" and "clinical trials," although apparently somewhat grudgingly
You may also be interested in...
Industry wanted FDA to impose a detailed set of internal requirements on itself before imposing PMRs, but in final guidance on the subject the agency does not do so.
Trump and Biden trade barbs in debate that included a suggestion by the president that coronavirus vaccine development delays are political and saw Biden questioned on whether he was contributing to vaccine hesitancy.