FDA Guidances

Many physicians ask me about training courses.  

What courses should they take to learn more about drug development.

Are there trainings or certifications they should get to help them show experience or expertise.

FDA Guidance documents are a great resource for learning about drug development.

Here are a few that will be helpful foundations to building your knowledge:

Adaptive Clinical Trial Designs:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-design-clinical-trials-drugs-and-biologics-guidance-industry

Clinical efficacy:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products

Safety reporting:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-inds-investigational-new-drug-applications-and-babe

Drug Labeling:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-human-prescription-drug-and-biological-products-implementing-plr-content-and-format

And the link to the MANY clinical trial related guidances: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents

There are many free resources available to physicians interested in making a transition to pharma/biotech. I recommend that you spend time on FDA’s website – there are LOTS of documents and trainings available that will further your understanding of clinical development, medical affairs and pharmacovigilance!

Ready to make a career transition to pharma/biotech… want to explore a way to use your medical training and knowledge in a fulfilling way without nights and weekends call or charting. Watch this webinar on Getting Past the Three Major Hurdles to a Career in the Pharma Industry HERE.