Latest From BASF SE
"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.
Sudarshan Jain, the new secretary general of the Indian Pharmaceutical Alliance and ex-Abbott managing director, wears many hats, including that of a senior advisor with a private equity advisory firm. He recounts having “survived in different cultures” in his career and outlines the priorities in his new role, amid continuing questions around generic quality.
Animal groups continue to call for a global ban on cosmetic animal testing while Cosmetics Europe advises outside jurisdictions to be prudent about prohibitions, noting that ingredient innovation has grinded to a halt in the EU in recent years. There does seem to be growing agreement between the camps that alternative methods are making important progress and show great promise compared with traditional standards.
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