FDA Presubmission Program – Requesting FDA FeedbackNSF International, Pharmaceutical Services
FDA Presubmission Program – Requesting FDA Feedback
The Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. The idea behind the Q-Submission program is not new and in fact, has often been a critical part of premarket review. However, a comprehensive system for FDA feedback mechanisms had not been well-defined prior to FDA's recent guidance documents issued in 2017 and 2018. In this course we will review these guidance documents and the recommendations provided within to make your next request for FDA feedback more effective and productive.
Outcome / Qualification etc.
By completing/passing this course, you will attain the certificate Medical Device Certificate
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.
NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...
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