This conversation will give more color to the FDA process of granting various designations to drugs in development. We'll dig deeper with a Regulatory Affairs Expert to examine the FDA designation process and understand how formulaic Breakthrough, Fast Track, Orphan and other designations are.
Key questions will be how formulaic each decision is vs. a review of the data and "endorsement" of the science. This call should help investors contextualize the importance of each designation without relying on a management team's positioning of the news.
Who's the Expert?
Dr Daniela Drago - PhD, RAC
- Global regulatory affairs expert and Assistant Professor and the Director Regulatory Affairs at George Washington University School of Medicine and Health Sciences.
- Prepares global regulatory submissions and advises firms on how to interact effectively with agencies to help companies to effectively develop and commercialize drugs, biologics, medical devices, and combination products.
- Frequent lecturer at international courses and workshops on topics including the NDA review process, filing a MAA in Europe, the 510K and substantial equivalence, the PMA pathway, labeling, regulatory intelligence, fast track and accelerated approval processes, pediatric regulations, and orphan drugs, and has published numerous articles within the field.
- Worked in industry and held senior positions in global regulatory and medical affairs at Bausch & Lomb, Reckitt Benckiser, Vifor Pharma, and F. Hoffman-La Roche.
Key Questions Investors Are Asking the Expert:
- Please describe your background and relevant experience working with the FDA.
- Can you walk me through at a high level each of the key designations the agency grants?
- Fast Track
- Accelerated Approval
- Priority Review
- Do any of the designations imply an endorsement of the application itself vs. severity of the disease or condition it is attempting to address?
- Is the only major difference between Breakthrough and Fast Track if other agents are already approved or not?
- Under Breakthrough Designation how much flexibility does the FDA have to accept a filing prior to all of the pieces of CMC being completed? For example if parts but not all of the process were validated could the FDA accept the filing if it deemed that the balance would be completed prior to approval? Is there a precedent for such an occurrence? How common or uncommon would that be?
If you’re interested in accessing this call on the FDA Designations and adding your questions for the expert visit here for the Expert Interview Details!