1 / 11

FDA Perspective on Review of Innovative Systems for Drug Delivery

FDA Perspective on Review of Innovative Systems for Drug Delivery. Perspective from CDER’s Division of Reproductive and Urologic Drug Products (DRUDP). Experience and Lessons Learned from Contraceptive and other Drug /Device Therapeutic Systems. Dan Shames MD Director, FDA/CDER/DRUDP.

iniko
Download Presentation

FDA Perspective on Review of Innovative Systems for Drug Delivery

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. FDA Perspective on Review of Innovative Systems for Drug Delivery Perspective from CDER’s Division of Reproductive and Urologic Drug Products (DRUDP)

  2. Experience and Lessons Learned from Contraceptive and other Drug /Device Therapeutic Systems Dan Shames MD Director, FDA/CDER/DRUDP

  3. Innovative Drug/Device Systems for Contraception • Norplant I,II, Jadelle (1990, 96, 01) • six and two rod systems • systemic levonorgestrel (LNG) • 5 year efficacy • 1000+ women-years preapproval experience • interactions mostly with CDER technical experts (chemists, clinical pharmacology, toxicology, microbiology)

  4. Innovative Drug/Device Systems for Contraception • Lunelle (2000) • Injectable E + P, systemic • Prefilled syringe or vial: both single dose only • Every month • 1000+ women-years preapproval experience • interactions mostly with CDER technical experts

  5. Innovative Drug/Device Systems for Contraception • Mirena (2000) • Intrauterine System • releases LNG locally • 5 year efficacy • 1000+ women-year preapproval experience • interactions with CDRH and CDER technical experts

  6. Innovative Drug/Device Systems for Contraception • Nuvaring (2001) • intravaginal ring • E+P systemically • insert for 21; remove for 7 days • 1000+ women-year preapproval experience • interactions mostly with CDER technical experts

  7. Innovative Drug/Device Systems for Contraception • Ortho-Evra (2001) • transdermal system • E+P systemic • apply every 7 days (3 out of 4 weeks) • 1000+ women-year preapproval experience • interactions mostly with CDER technicalexperts

  8. Lessons Learned by DRUDP • The Good News (mostly it goes well) • we can work with device technical experts (from CDER and CDRH) in a productive and efficient manner to review innovative drug delivery systems • there were few clinical trial design conflicts when sponsor met CDER standards for evidence • development went well when sponsor knew of CDER’s evidence requirements “a priori”

  9. Lessons Learned by DRUDP • The Other News (when it doesn’t go well) • sometimes the systems are really “out of the box” • who is “in charge” CDRH versus CDER (turf ?) • Culture Clashes • the pointy headed bureaucrats whose main goal is to keep things off the market because they have no regard for the entrepreneurial spirit and “good ole American ingenuity” versus • those people who will approve anything that doesn’t blow up when they plug it in, regardless of consequence to patient safety

  10. Lessons Learned by DRUDP • Culture Clashes (continued) • the engineers versus the doctors • reasonable versus substantial evidence • big Pharma versus small firms

  11. Lessons Learned by DRUDP • Good News Again (the future) • Office of Combination Products is helping to “bridge the gap” and improve the processes • improved understanding between CDER, CDRH reviewers regarding the processes and regulations • getting the message out that development plans should be worked out early • most staff at CDER, CDRH enjoy working on innovative products and are well motivated to assist the sponsors and improve our internal processes

More Related