Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
The U.S. Food and Drug Administration is putting a halt to the sale of alleged treatments for COVID-19 due to concerns about the safety risks these products could have to the public.
The U.S. Food and Drug Administration issued a warning letter to Juul Labs Inc. over the company’s marketing practices for e-cigarettes.
Integra Lifesciences Holdings Corp. received a warning letter from the U.S. Food and Drug Administration regarding the medical device maker ‘s manufacturing facility in Boston.
The U.S. Food and Drug Administration rebuked 17 companies against selling unapproved products which claim to treat Alzheimer’s disease and other serious ailments.
Akorn Inc. received a warning letter from the U.S. Food and Drug Administration following an inspection of the generic drugmaker’s Decatur, Illinois manufacturing plant during 2018.
The U.S. health regulator warned a California-based manufacturer and retailer against advertising its e-cigarette liquids with nicotine in a way that may cause the products to resemble kid-friendly food like juice boxes and cookies.
Teva Pharmaceutical Industries said its 2018 results would be weaker than expected and that the company might encounter delays for an important new migraine drug, pushing the drugmaker’s shares down more than 9 percent.
Shares of South Korea-based Celltrion were down more than 5 percent after the company announced it received a warning letter from the U.S. Food and Drug Administration after the regulatory agency inspected a company drug manufacturing facility.
The U.S. FDA issued a warning letter to Imprimis Pharmaceuticals Inc. accusing it of making false or misleading claims that its compounded eye medications had the agency’s approval.