The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...
On December 17, 2024, the Company conducted a Submission Issue Request (SIR) meeting with the FDA. Management believes its comprehensive plans to address the Additional Information Request (AIR ...
Kazia Therapeutics updates paxalisib's regulatory progress after FDA discussions on glioblastoma data, highlighting plans for ...
Pfizer ’s executive team is using Mar-a-Lago for a planning meeting over several days, the people said. While there is no scheduled meeting between Bourla and Trump, the pair are likely to interact ...
“FDA determines that the tirzepatide injection ... the evidence demonstrating that Lilly’s supply is currently meeting or exceeding demand and that, based on our best judgment, it will meet ...
After the British study led authorities in Europe to warn about dyes like Red 40, the FDA convened a meeting of its food advisers in 2011 to review their safety. The panel voted narrowly against a ...
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