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In this edition of Quick Notes are drug approvals to treat hemophilia B, rare genetic disorder WHIM, cervical cancer, cluster seizures in children with epilepsy and a new formulation of a drug for movement disorders. Read More
This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA labeling statements, use of human- and animal-derived materials in the manufacture of CGT and TEMP products, safety testing of human allogeneic cells. Read More
Using Sarepta’s treatment for Duchenne muscular dystrophy (DMD) as an example, a researcher from the Institute for Clinical Review (ICER) said in a recent article that the FDA should be cautious in granting full approval to drugs that fail confirmatory tests. Read More
“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of Internal Medicine. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More
Most of the new oncology indications approved under Real Time Oncology Review (RTOR) relied on surrogate endpoints that were never confirmed as clinically effective in postmarketing trials, according to a research letter published in JAMA Network Open. Read More
A recent Warning Letter to www.dashpct.com, a Malaysian online marketer, should send a clear message that the agency is getting tough on companies selling unapproved and misbranded semaglutide (Rybelsus/Ozempic/Wegovy). Read More