GESTIÓN EN SALUD PÚBLICA: FDA In Brief: FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health

viernes, 31 de enero de 2020

FDA In Brief: FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-updates-prioritization-policy-original-abbreviated-new-drug-applications-amendments?utm_campaign=013020_FIB_FDA%20Updates%20Prioritization%20Policy%20for%20Generic%20Drug%20Applications&utm_medium=email&utm_source=Eloqua

FDA In Brief: FDA Updates Prioritization Policy for Original Abbreviated New Drug Applications, Amendments and Supplements to Maximize Impact on Public Health

The following quote is attributed to Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research:

“Today, the U.S. Food and Drug Administration is making critical updates to our policy for prioritizing the review of abbreviated new drug applications (ANDAs) to advance the public health, efficiently allocate limited agency resources and ensure fairness to applicants, which reflects the FDA’s longstanding practice to prioritize the review of ANDAs that would have the greatest potential impact on public health, if approved.

“Under the previous prioritization policy, roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of ...