The US Food and Drug Administration (FDA) published a new grant call, on Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional. The purpose of this notice of funding opportunity (NOFO) is to address topics related to the use of digital health technologies (DHTs) for […]
Read MoreThe grant application submission deadline is coming up in just 2 months! The application submission deadline for this grant funding opportunity is February 13, 2024. Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) The purpose of this grant is to support efficient and innovative natural history studies that advance medical product development in rare […]
Read MoreThe Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) announces the availability of funds for fiscal year (FY) 2024 to support natural history studies for rare diseases and conditions. This funding opportunity is intended to support prospective or retrospective, efficient, and innovative natural history studies with a focus on collaborative and standardized approaches to […]
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The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal year (FY) 2024 to support natural history studies for rare diseases and conditions. This funding opportunity is intended to support prospective or retrospective, efficient, and innovative natural history studies with a focus on collaborative […]
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The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal years (FY) 2023 – 2025 to support clinical trials for rare diseases and conditions. The purpose of this funding opportunity announcement is to fund clinical trials of products evaluating efficacy and/or safety in support of a new […]
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FDA’s Rare Disease Endpoint Advancement (RDEA) Pilot Meeting Program is accepting RDEA proposals for this quarter until September 30, 2023. The RDEA Pilot Meeting Program is designed to support novel endpoint efficacy development for drugs that treat rare diseases by providing a mechanism for sponsors to collaborate with FDA throughout the efficacy endpoint development process. […]
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The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal years (FY) 2023 – FY 2025 to support clinical trials for rare diseases and conditions. The purpose of this funding opportunity announcement is to fund clinical trials of products evaluating efficacy and/or safety in […]
Read MoreThe U.S. Food and Drug Administration (FDA) announced a new funding opportunity for the FDA Rare Neurodegenerative Disease Grant Program to support efficient natural history studies and/or biomarker studies that fill unmet needs for rare neurodegenerative diseases for children and adults. Through the support of prospective natural history and/or biomarker studies with high quality and interpretable data elements, FDA […]
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Don’t miss the Rare Disease Day organized by FDA, a virtual public meeting, on February 27th, 2023, 9:00 am – 4:45 pm ET, in global observance of Rare Disease Week. This year’s theme is “Intersections with Rare Diseases – A patient focused event.” Participants will have the unique opportunity to: Hear directly from the FDA […]
Read MoreIn addition to the Orphan Products Grants Program that the Office of Orphan Products Development (OOPD) currently administers, a new grant program was established this year by the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS) named the FDA Rare Neurodegenerative Disease Grant Program. This new program will be administered […]
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