Haystack Actively Educating FDA About Rare and Ultra Rare Patient Circumstances
Inside Health Policy and AGENCY IQ highlight Haystack Project’s call for change at recent FDA Listening Session. Conflict of interest rules must accommodate the critical need for rare disease clinician experts on Advisory Committees with appropriate disclosures. Read Inside Health Policy article here. Click here to review the FDA slides submitted. Read AGENCY IQ article here.
Haystack Project was invited to speak at the FDA meeting on Rare Diseases hosted by Duke Margolis
Haystack Project was invited to speak at the National Academies Meeting
Link to the article with press coverage of the meeting. See page 3 for what the reporter had to say about Haystack’s participation.
Click here for the Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union.
Click here for the presentation.
December 2022
HAYSTACK SUCCESSFULLY ADVOCATED FOR PATIENTS AND EXPERTS TO HAVE AN INCREASED ROLE
DURING THE FDA REVIEW PROCESS FOR TREATMENTS FOR RARE DISEASES!
PRESS RELEASE JUNE 14, 2022
Haystack Project Applauds the Inclusion of the HEART Act in the User Fee Package
Thank you, Senator Casey for the Amendments #3 and #4 – Putting some of the heart back in the HEART Act today! Appreciate all your hard work. Patients from PA – please drop Sen. Casey a big thank you note! @SenBobCasey.
“I drafted the HEART Act because we can do more to better incorporate the patient and rare disease medical experts in the FDA process - especially as it relates to rare and ultra-rare conditions.”
