![]() ![]() And there is nothing of significance on the FDA guidance agendas. We’ve also seen no major guidance documents since 2018. Certainly, enforcement on the FDA side continues to be very quiet with only a handful of OPDP letters seen last year. We haven’t talked yet about advertising and promotion. Kellie Combs: I’ll weigh in, Greg, just for a moment. That draft guidance could shed more light on how those alternative tools are going to be used in the context of assessing facilities that are named in NDAs and the like. FDA did try, in many cases, to exercise flexibility and use records requests, remote regulatory assessments, and these other “alternative tools” to find a way to assess records from facilities, GMP compliance at facilities, GCP compliance at trial sites, etc., but it seems that FDA is moving towards formalizing a lot of these policies now that they’ve had some experience with them. And in certain situations where FDA deemed that an inspection was essential, the approval of those applications had to be held up until FDA was able to travel to the relevant location and inspect the facility. This guidance stems from the pandemic, where FDA was, in many cases, unable to inspect manufacturing facilities named in pending applications. Separately, new to the CDER Guidance Agenda this year is a planned draft guidance on the use of alternative tools to assess manufacturing facilities named in pending applications. It’ll be interesting to see what actually comes out this year, particularly if there’s a long-awaited guidance on the 503B prohibition on wholesaling-it’s something that the compounding industry has been looking for for a while. We also saw a number of compounding specific rules on the FDA’s rulemaking agenda. First, in the CDER Guidance Agenda, we saw, as has often been the case in recent years, there are a number of compounding guidances. On the policy side, there are a few other things I’m keeping my eye on this year. Why don’t we throw it out to the group-who would like to start? We’re going to go around the group and see what additional thoughts people have on their minds for developments to expect in 2023. ![]() Last but not least, we’re going to do a lightning round. What you’ll be listening to today is part four of that conversation, which was our lightning round covering a variety of topics, such as anticipated guidance on drug compounding, advertising and promotion, the redesign of the Human Foods (regulatory) Program, and more. ![]() We had a robust discussion that we are releasing as a four-part podcast series. I was joined by Kellie Combs, Josh Oyster, and Beth Weinman, from our life sciences regulatory and compliance practice group, and Margaux Hall, from our health care practice group. office to discuss our expectations for the coming year. Earlier this month, I sat down with several of my colleagues from our Washington, D.C. I’m Greg Levine, head of the life sciences regulatory and compliance practice group at Ropes & Gray, based in Washington, D.C. life sciences regulatory outlook podcast series. Greg Levine: Hello, and welcome to our 2023 U.S. Topics discussed include anticipated guidance on drug compounding, advertising and promotion, the redesign of the Human Foods Program, and more. This fourth episode will feature a lightning round where we cover additional insights on expected developments not covered earlier in the series. and the potential impact on life sciences companies in 2023. Join Ropes & Gray’s life sciences and health care attorneys on a four-part podcast series exploring regulatory, compliance and enforcement changes emanating from Washington, D.C.
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