We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The agency is “taking new steps to help ensure that a product’s labeling provides actionable and complete information about the clinical evidence supporting an accelerated approval,” Commissioner Gottlieb said. Read More
The agency plans to issue guidance clarifying how the accelerated approval pathway may be used when a gene therapy targets a serious disorder not addressed by available therapy. Read More
Sponsors can use postmarket adverse event data, drug use data, and observational or epidemiological data, in addition to stakeholder input for their REMS assessments, the agency said. Read More
The FDA issued revised guidance on electronic submissions of drug master files, extending the timetable for Type III submissions by another year to May 5, 2020. Read More
Competition is the key to lower drug costs, the Pharmaceutical Care Management Association (PCMA) said in a letter to lawmakers in defense of pharmacy benefit managers. Read More
Drugmakers were conspicuously absent on Tuesday from two drug pricing hearings on Capitol Hill, where lawmakers called out big pharma for setting high drug prices through manipulative means — and for refusing to show up to testify. Read More
Medicare and Medicaid beneficiaries received more insulin than they were prescribed, and the company billed the federal programs accordingly. Read More
A New York pharmacist group claims the misuse of “spread pricing” by the state’s pharmacy benefit managers has led to increased drug prices – especially for generics. Read More
PhRMA picked holes in a proposed Centers for Medicare & Medicaid Services rule increasing Medicare Advantage and Part D plans’ power to negotiate drug prices. Read More