FDA Opens the Pre-Sub Program to Compliance Actions, Including Form 483s and Warning Letters | Morgan Lewis
To embed, copy and paste the code into your website or blog: Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through the Q-submission program (also referred to as a “pre-submission”) may be limited. To start off the new calendar year, FDA issued a revised version of its guidance document on the Q-submission program on January 6, 2021, “ Obtaining feedback on submissions that may qualify for FDA’s recently announced S...