FDA allergenic product guidelines
Revised draft guideline is now available through the agency's Biologics Information Staff, Building 29, Room B-16, 8800 Rockville Pike, Bethesda, Maryland, 20892. The telephone number is 301/496-9508. Comments on the draft proposal to assist manufacturers in the design of clinical studies for allergenic products are due April 3 at FDA's Dockets Management Branch ....
You may also be interested in...
Medtech Insight spoke to attorney Greg Dadika about mass tort litigation, including industry trends, how to find the right law firm, and when it’s the right time to settle a suit. See what Dadika, an attorney at the law firm Greenberg Traurig LLP, said about it here.
AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte.
Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.