FDA+ roundup: Sen. Burr on strengthening FDA's readiness; ICH guideline adoption; Longtime FDA lawyer retires and more
While praising the FDA’s quick, agile and frequent use of the emergency use pathway to authorize Covid-19 tests, drugs and vaccines, the Senate health committee’s top Republican recently explained what, in hindsight, the agency needs to do better.
North Carolina Sen. Richard Burr’s new policy brief on FDA points to early issues for the agency in the pandemic, such as its testing woes, due to the agency’s “overly strict and initially inflexible criteria,” which “did not encourage innovative test development and instead limited the tests available to the public and health care providers to help detect, diagnose, and surveille for COVID-19.” He also pointed to more necessary work around the supply chain, as some drugs and tests fell into shortage early on and were slow to recover.
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