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This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
The discounts drug manufacturers are forced to offer pharmacy benefit managers (PBM) and insurance companies on their products are driving the sharp rise in drug prices, according to a study published Wednesday in JAMA Network Open. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a seven-page untitled letter informing Xeris Pharmaceuticals that its website advertising the drug Recorlev (levoketoconazole) makes “false or misleading claims and representations about the safety and efficacy” of the tablets. Read More
The National Association of Manufacturers (NAM) and the Washington Legal Foundation (WLF) have entered the “right to repair” legal fray, questioning the Library of Congress’s (LOC) ability to grant copyright exemptions to third-party repair companies without the opportunity for judicial review. Read More
Pfizer has become the latest pharma company to unveil serious drug shortages in the ongoing U.S. drug supply crisis, announcing the discontinuation of two penicillin products and the limited supply of several penicillin syringes. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as webinars on subjects ranging from GxP system verification and FDA’s sterilization pilot. Read More
Specialized scientific liaisons will be key to moving rare disease drugs through the Accelerating Rare Disease Cures (ARC) Program, according to CDER Director Patrizia Cavazzoni. Read More
An FDA final guidance on premarket submissions for device software functions recommends a risk-based approach to help determine whether the sponsor should submit basic or enhanced documentation to explain its use of new data processing methods. Read More
FDA’s method for assessing requests for major-to-minor reclassifications for complete response (CR) letters is described in the just-released Manual of Policies and Procedures (MAPP). Read More
The recall of Walnut Wearable smart thermometer, a device that continuously monitors body temperature of infants and children up to 6 years, is now deemed FDA Class I, the most serious type of recall as use of the device may cause serious injuries or death. Read More
When preparing for meetings with regulators, it is essential that you view them as partners in the drug development process. Mark Lane, Adair Turner and Patrick Larcier of PharmaLex outline some key steps in the process.Read More
Several chambers of commerce have sued HHS and CMS over the Inflation Reduction Act (IRA) claiming that the prescription drug price control program is “a violation of America’s fundamental constitutional requirements of limited government, property rights, the rule of law, and the separation of powers.” Read More