• Cancellation of the May meeting of the AAPS Regulatory Sciences Community

    Hi everyone,

    Our May AAPS Regulatory Sciences Community meeting will be cancelled. In place of the meeting, please send written feedback to me (Jen Brown: [email protected]) on the following topics by 1 p.m. Friday, May 17th. I will then issue a summary of the feedback received.

    Thank you,


    Discussion Topics:

    1. Meeting date/time
      1. Starting with August meeting, move to noon at Mondays (12:05-12:55 p.m.); third Monday of each month – any objections?
    2. New regulatory guidances – Allison Radwick
      1. Update on involving the AAPS Scientific Advisory Committee (SAC) in these discussions?
    3. FDA draft guidance “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies”
      1. Update on response team – Raja
      2. Were representatives of the In Vitro Release and Dissolution Testing Community (Sanjaykumar Patel) and BE/BA Community added to the team?
    4. PharmSci360
      1. Please provide all sessions, panels, Hot Topics, Rapid Fires (submissions due June 14th) etc that you will be contributing to so that we can coordinate a full list of sessions where the Regulatory Sciences Community is contributing. Thank you!
    5. Separate session Patient Centric Specifications? Stan Altan and Sandra Suarez
    6. Excipients Community May 23rd Open Scientific Discussion on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
      1. Excipients Community to moderate
      2. Plans for co-promotion (Jen and Khushboo to promote for RS)
    7. Webinar: “TiO2-Free Drug Products: Challenges During Drug Product Development” – Tahseen Mirza
      1. With the IV/IVC Community
      2. Status update? Speakers identified?