FDA hears calls for more post-approval monitoring of products at drug-development meeting, a reminder to sponsors that patient pressure can prod the agency for more than just streamlined approvals.
The hemophilia community is telling FDA that it wants access to post-market safety surveillance data on factor replacement therapies in order to better understand the development of inhibitors, or neutralizing antibodies, that many patients experience.
Patients aired their concerns at a Sept. 22 patient-focused drug development meeting organized by the agency’s Center for Biologics Evaluation...
Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.
New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.
The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
