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…
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…
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…
The International Council for Harmonisation (ICH) has adopted its Q5A(R2) guideline on viral safety evaluation of biotechnology products. Source: Drug Industry Daily
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.…
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…
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…
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…
Attorneys general from 24 states and Washington, D.C. have sent the FDA a letter urging the agency to strengthen guidance and provide clear warning labels regarding incorrect pulse oximeter readings…
Upcoming events in the coming weeks and months include two FDA advisory committee meetings, MAGI 2024: The Clinical Research Conference as well as webinars on choosing the right IRB review…