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Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding...
Program/Project Management Job in Lebanon about Recovery and Reconstruction, requiring 3-4 years of experience, from DRC; closing on 23 Jun 2021
On March 26, 2021, the Food and Drug Administration (FDA) issued a new Federal Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. 1 As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities 2 and qualifying submitters of OTC monograph order requests (OMORs). 3 The fees are meant to support FDA in its OTC monograph drug activiti...
FDA Foolishly Smacks Struggling Distillers With $14,000 Fee For Producing Hand Sanitizer FDA Foolishly Smacks Struggling Distillers With $14,000 Fee For Producing Hand Sanitizer (UPDATE) The FDA has backed down from this fee collection program after being told to do so by the federal Department of Health & Human Services. Read more on this latest development here. Editor’s Note: It is our strong opinion here at The Whiskey Wash that this is a startling poor call on the part of the FDA at a time when these distilleries stepped up to do a decidedly public service. We call upon the government ...