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The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Quality agreements between companies and third-party vendors should explicitly define key manufacturing roles and responsibilities and establish expectations for communication, such as by providing key contacts for both entities, says a regulatory expert. Read More
Public health officials, patient advocacy groups and health scholars have filed amicus briefs supporting the U.S. government as it fights a lawsuit from AstraZeneca claiming the Inflation Reduction Act’s (IRA)drug pricing negotiation provisions are unconstitutional. Read More
Over the past week, the FDA issued final guidance on real-time oncology review and cosmetic product facility registration and product listing. Read More
Untitled letters sent to Otsuka Pharmaceutical and Evofem Biosciences alleging false or misleading claims that inflated the effectiveness of the products in direct-to-consumer (DTC) advertising were recently released by the FDA Office of Prescription Drug Promotion (OPDP). Read More
A sock that performs pulse oximetry measurement for infants will be available OTC for U.S. consumers by the end of this year, following the FDA’s Wednesday De Novo clearance of Owlet’s Dream Sock baby monitor. Read More
After committing in March to cut 65 percent off the price of its long-lasting insulin Levemir (insulin detemir), Novo Nordisk has announced that it will discontinue its marketing of the product in the U.S. with supply disruptions beginning as early as January. Read More
The Senate Finance Committee voted 26-0 in favor of the Better Mental Health Care, Lower Drug Cost and Extenders Act which addresses pharmacy benefit manager (PBM) practices that sponsors Sen. Ron Wyden (D.-Ore.) and Sen. Mike Crapo (R.- Idaho) say drive up the cost of drugs. Read More
The FDA’s proposed transformation of the Office of Regulatory Affairs (ORA) will not only see the office transfer all compliance functions to product centers but could also lead to more efficient inspection planning and execution as well as more effective and timelier regulatory compliance actions. Read More
The FDA has extended the effective date of the guidance “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers” until Aug. 7, 2024, unless a revised final guidance is issued before that date. Read More
The FDA has deemed as class I the company’s recall of certain Teleflex and Arrow International Pressure Injectable Catheter Kits for a mislabeling issue and Nurse Assist has recalled certain lots of irrigation water for a lack of sterility assurance. Read More