FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam 2026 - Free NABP Practice Questions and Study Guide

The FDA typically aims to review New Drug Applications (NDAs) within a standard timeframe of 6 months for priority reviews and approximately 10 months for standard reviews. This structured review period allows the agency to thoroughly evaluate the safety and efficacy data of new medications presented by pharmaceutical companies.

Priority reviews are often granted to drugs that offer significant improvements in treatment or provide effective treatment where none exists, necessitating a more expedited review process. Meanwhile, the standard review timeline of around 10 months reflects the complexity and importance of ensuring that new drugs meet rigorous safety and efficacy standards before they are approved for public use.

A timeframe of 6 months aligns with the FDA's commitment to swift but thorough evaluation, ensuring that potential new therapies can reach patients in a timely manner without compromising safety and effectiveness.

Longer durations such as one year or two years do not represent the FDA's current standard review timelines for NDAs, as the agency aims for efficiency in its review processes, while still upholding stringent regulatory standards.