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Ironwood Pharmaceuticals’ Linzess (linaclotide) is the first drug to receive FDA approval to treat functional constipation in children age six to 17 years with a recommended daily dosage of 72 mcg orally. Read More
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
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
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
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
Drugs or indications should not “maintain approval if confirmatory studies fail, even while additional confirmatory studies are pursued,” the researchers say. Read More