FDA and Pharmacy Weekly Digest - September 17

Alerts / September 17, 2019
Food/Dietary Supplements

FDA Issues Guidance on Fish and Fishery Products – The FDA released a draft guidance “intended to clarify steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine), and decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).”


FDA Alerts Patients to Issues with Ranitidine – The FDA released a press announcement indicating that “some ranitidine medicines … contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

Medical Devices

FDA Publishes Four Final 510(k) Guidance Documents – The first final guidance provides “guidance on how to format an original submission for a Traditional or Abbreviated premarket notification (510(k)) submission. This guidance document provides only a general framework for the format and content of a Traditional or Abbreviated 510(k).” The others address the FDA’s refusal to accept policy, abbreviated 510(k)s and special 510(k)s.


FDA Announces Efforts to Combat Youth E-cigarette Use – Following an announcement from the Trump administration, the FDA announced that it “intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products. The FDA plans to share more on the specific details of the plan and its implementation soon.”

FDA Publishes Information About Lung Illnesses Associated With Vape Products – The FDA stated, “Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory illness associated with use of vaping products. The FDA and CDC are working closely with state and local health officials to investigate these incidents as quickly as possible, and we are committed to taking appropriate actions as a clearer picture of the facts emerges.”


FDA Holds Public Hearing on Opioid Analgesics – The FDA held a public hearing titled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The FDA stated, “This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new pre-approval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.”

Authorship Credit: Lindsay P. Holmes

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