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U.S. FDA
Here you'll find the latest US Food and Drug Administration news and information. Privacy Policy -
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U.S. FDA 9h
FDA engages with cancer patients and advocacy groups and encourages research into the measurement of patient experiences so that we can use this information to generate science-based recommendations for patient-centered regulatory policy
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U.S. FDA 10h
Secondhand smoke causes more than 30,000 coronary heart disease deaths in the U.S. per year. During find out more about free text messaging programs to help you get and stay smoke-free. via
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U.S. FDA 11h
That's it for the . Thanks to for hosting!
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U.S. FDA 11h
Replying to @US_FDA
A6: is developing a series of methodological guidance on the collection of patient experience data, and the use of such data and related information in drug development. To learn more, please visit: .
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U.S. FDA 11h
Replying to @US_FDA
A6: has recently issued draft guidance on ways stakeholders can help advance drug development by sharing patient experience data. For more information, please visit: . Comments on the draft guidance are due by March 21st.
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U.S. FDA 11h
Replying to @US_FDA
A6: Orphan incentives include clinical trial tax credits, fee waivers, and marketing exclusivity Link to designation program page.
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U.S. FDA 11h
Replying to @US_FDA
A6: DYK FDA has a webinar on tips for creating an orphan-drug designation application at . Also view ’s orphan-drug designation application form at .
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U.S. FDA 11h
Replying to @US_FDA
A6: Join us March 15 for the 2019 FDA Oncology Center of Excellence Childhood Cancer Advocacy Forum (in person or online). Register now:
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U.S. FDA 11h
Replying to @US_FDA
A6: Read FDA/CDER’s “Advancing Health Through Innovation: 2018 New Drug Therapy Approvals” report to learn about important new drug approvals in 2018 & innovative regulatory tools
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U.S. FDA 11h
Replying to @US_FDA
A6: Learn more about HUDs visit -
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U.S. FDA 11h
A6: Have you seen video that describes how is administering funding to support innovative clinical trial methods and research for the millions of people with rare diseases?
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U.S. FDA retweeted
FDA Patient Affairs 11h
A6. Are you a patient, caregiver, or advocate who wants to connect with FDA, and don’t know where to begin? Patient Affairs can help! Connect with us
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U.S. FDA 11h
Replying to @US_FDA
FDA plans to hold a public meeting to obtain input on the impacts of rare diseases on daily life and assess commonalities that may help advance medical product development for rare diseases.
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U.S. FDA 11h
Replying to @US_FDA
CBER’s Regenerative Medicine Advanced Therapy (RMAT) Designation Program aims to expedite the development & review of eligible regenerative medicine therapies intended for patients with unmet needs in serious conditions
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U.S. FDA 11h
Replying to @US_FDA
A5: In 2012, established the Patient-Focused Drug Development () initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. To learn more, please visit:
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U.S. FDA 11h
Replying to @US_FDA
A5: publishes Rare Diseases: Common Issues in Drug Development Guidance for Industry Draft Guidance
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U.S. FDA 11h
Replying to @US_FDA
A5: /CDER awarded 5 Rare Pediatric Disease Priority Review Vouchers (PRV) in 2018 -
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U.S. FDA 11h
Replying to @US_FDA
A5: FDA provided funding on 9/1/18 to 5 Pediatric Device Consortia. Read More -
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U.S. FDA 11h
Replying to @US_FDA
A5: funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children.
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U.S. FDA 11h
Replying to @US_FDA
A5: issued a new RFA for FY2020 to support efficient and innovative clinical studies of products that address unmet needs in RDs or provide highly significant improvements in treatment or diagnosis. RFA due date is June 25, 2019.
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