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Expert Interview

Slingshot members are talking to an expert! The topic is:

A look at the FDA designation process. How formulaic is Breakthrough, Fast Track, Orphan etc?

Ticker(s): CELG, AGIO, TEVA, LXRX, SRPT

Who's the expert?

Name: Dr Daniela Drago - PhD, RAC

Institution: George Washington University

  • 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. 

Interview Questions
Q1.

Please describe your background and relevant experience working with the FDA.

Added By: joe_mccann
Q2.

Can you walk me through at a high level each of the key designations the agency grants?

  • Fast Track
  • Breakthrough
  • Accelerated Approval
  • Priority Review
  • Orphan

Added By: joe_mccann
Q3.

Do any of the designations imply an endorsement of the application itself vs. severity of the disease or condition it is attempting to address?

Added By: joe_mccann
Q4.

Is the only major difference between Breakthrough and Fast Track if other agents are already approved or not?

Added By: joe_mccann
Q5.

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? 

Added By: user59b1538a
Q6.

Fill out creator's second question. What are the key specific benefits and requirements for each designation?

Added By: user59b1538a
Q7.

How does the FDA detect fraud in submissions? Clinical site audits? Statistical analysis for abnormalities? Honor system? 

Added By: joe_mccann
Q8.

The FDA guidelines have criteria such as "nonclinical or clinical data demonstrate the potential to address unmet medical need". What type of review or work does the FDA do to make this decision? 

Added By: joe_mccann
Q9.

Do you need fast track to get accelerated approval or priority review? 

Added By: user59b1538a

Are You Interested In These Questions?

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Reason

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