by Pill Pals | Oct 31, 2024 | News
[10/30/2024] FDA is warning consumers to not purchase or use Skin-Cap aerosol spray products because they may contain undisclosed steroids. This product, sold by Chemigroup France, formerly known as Cheminova Laboratories, has been found for sale on skincap.com,...
by Pill Pals | Oct 31, 2024 | News
[10/30/2024] The Food and Drug Administration is advising consumers not to purchase or use ITCHA XS, a product promoted and sold for weight loss on various websites, and possibly in some retail stores. This product was identified during an examination of international...
by Pill Pals | Oct 31, 2024 | News
Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal Food, Drug, and Cosmetic Act. Section 507 includes transparency provisions that apply to requestors’...
by Pill Pals | Oct 31, 2024 | News
Spanish (Español) Product Slivered onions previously served on McDonald’s Quarter Pounder burgers are the likely source of contamination, based on epidemiologic and traceback data. McDonald’s is no longer using slivered onions on Quarter Pounders at stores in affected...
by Pill Pals | Oct 31, 2024 | News
On This Page Date: November 20, 2024 Time: 9:00 AM – 12:30 PM ET Location: Event Location FDA Headquarters FDA headquarters in White Oak, MD10903 New Hampshire AveSilver Spring, MD 20903United States The Food and Drug Administration (FDA or Agency) is announcing...
by Pill Pals | Oct 30, 2024 | News
Docket Number: FDA-2023-D-0093 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post approval phases for orally...
by Pill Pals | Oct 30, 2024 | News
FDA is reminding compounders to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile. The agency is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make...
by Pill Pals | Oct 30, 2024 | News
Quality Matters Related to Components of a Drug FDA continues to identify several issues related to repackagers of bulk drug substances, also called active pharmaceutical ingredients (APIs), and excipients used to compound drugs that have resulted in patient harm. ...
by Pill Pals | Oct 30, 2024 | News
October 29, 2024 Summary of the Issue: The Food and Drug Administration is advising the public, including consumers, health care professionals, and community-based organizations, health departments, and clinics where HIV self-testing programs are available, that HIV...
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