Latest From BASF SE
The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.
With two new US investors on board, NST is financed to complete a Phase IIb trial of icosabutate in non-alcoholic steatohepatitis.
"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."
Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.
- Therapeutic Areas
- BASF AG
- Western Europe
- Parent & Subsidiaries
- BASF SE
- Senior Management
Jurgen Hambrecht, Chmn. & CEO
Kurt Bock, CFO
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