The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
Tag Archive for: CDER
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
As the number of rare disease drugs on the market exponentially increases, marketers will have to ramp up efforts to persuade payers of the value of these often costly treatments.
Last year CDER approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in its annual New Drug Therapy Approvals report. The agency also approved drugs in new settings, such as for new uses and patient populations.
The report summarizes various measures of the pharmaceutical industry’s ability to deliver quality drugs to U.S. patients and consumers.
The agency revised its EUA to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
