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First Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patiOlympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles
CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching duringYoCrunch® Products Voluntarily Recalled by Danone U.S. Due to Potential Presence of Plastic Pieces in Dome Topper
Danone U.S. is voluntarily recalling YoCrunch® products sold at retail stores nationwide due to the potential presence of plastic pieces in the dome topper. If consumed, the plastic pieces could potentially cause a choking response. The issue is isolated only to the separately packaged topper and doCDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.Black Thai Honey may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Black Thai Honey, a product promoted and sold for male sexual enhancement on various websites, including www.honeypacks.com, and possibly in some retail stores.Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication – FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o
