FDA Approves Cholera Vaccine
FDA approved Vaxchora intended for travelers who are at risk for the disease.
FDA approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults, the agency said in a June 10, 2016 press announcement. Although cholera is rare in the United States, FDA said travelers to countries with poor sewage and sanitation treatment are at risk for the disease. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.
FDA granted Vaxchora fast track designation and priority review status. PaxVax Bermuda, the drug’s manufacturer, also received tropical disease priority review. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
Vaxchora was evaluated in adults ages 18â64 years of age in four clinical trials in which 3235 participants received Vaxchora and 562 received a placebo. According to FDA, 93% of Vaxchora recipients produced antibodies indicative of protection against cholera.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
