The FDA's decision makes the erectile dysfunction (ED) tablet the first phosphodiesterase 5 (PDE-5) inhibitor in the US to undergo an AUT. AUTs are critical in assessing the real-world application ...
The agency previously placed a clinical hold on the company’s planned actual use trial (AUT) for the conversion, citing problems with protocol design. AUTs are a key step in the FDA’s process ...
'Den of Thieves 2: Pantera' Is Good but Lacks What Made the Original Great. While a solid heist movie, ...
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