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OOPD News, Events and Archives

Calendar of Events:

Past Events in 2014:

  1. Joint EMA/FDA/PMDA Orphan Designation Workshop, March 10, 20146See Disclaimer page regarding links to external sites
  2. Rare Disease Day 2014
  3. Public Workshop - Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases, January 8, 2014
  4. Public Workshop - Complex Issues in Developing Drug and Biological Products for Rare Diseases, Janauary 6-7, 2014

 Past Events in 2013:

  1. Orphan Drug Regulations: Regulatory History, June 12, 2013
  2. FDA Marked Rare Disease Day, February 28 - March 1, 2013, NIH Natcher Auditorium, Bethesda, MD
  3. Webinar on Accelerated Approval - Duchenne Disease, presented by Robert J. Temple, M.D., Deputy Center Director for Clinical Science, CDER, February 20, 2013
  4. FDA Marked Orphan Drug Law Milestone celebrating the 30th Anniversary of the passage of the Orphan Drug Act on January 7, 2013 from 10:30 am to 12:30 pm - White Oak Campus CSU Room 2047

 Past Events in 2012:

  1. The Science of Small Clinical Trials Course, November 27-28, 2012, FDA White Oak Campus, Silver Spring, MD
  2. DIA/NORD US Conference on Rare Diseases, October 22-24, 2012, Washington, DC
  3. disclaimer icon disclaimer icon FDA/EMA Orphan Product Designation and Grant Workshop, October 12, 2012, Silver Spring, MD
  4. disclaimer icon 3rd Conference on Clinical Research for Rare Diseases, October 2, 2012, Rockville, MD disclaimer icon  
  5. disclaimer icon FDA OOPD Pediatric Medical Devices Workshop, September 24, 2012, Silver Spring, MD
  6. Workshop on Natural History Studies of Rare Diseases/May 16-17, 2012, Bethesda, MD
  7. Rare Diseases Take Spotlight in Annual Events/February 29 and March 1, 2012, Bethesda and Silver Spring, MD
  8. FDA at Rare Disease Day/February 28, 2011, Bethesda, MD


Archived Grant Notices:

FDA Awards 15 Grants to Stimulate Drug, Device Development for Rare Diseases

FDA Awards seven Grants to Stimulate Development of Pediatric Medical Devices

Fiscal Year 2012 OPD New Awards

RFA FD-09-001 for Receipt Dates 2009 and 2010, Dated: 12/18/2008


Archived Federal Register Notices:

Orphan Drug Regulations Final Rule December 29, 1992

Orphan Drug regualtions Proposed Rule January 29, 1991