September 30, 2024
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1) Receipt Date: June 25, 2019 FOA Number: RFA-FD-20-001 Funding Opportunity Purpose: The purpose of […]
September 30, 2024
OOPD Background: The FDA Office of Orphan Products Development (OOPD) was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, […]
September 30, 2024
On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years […]
September 30, 2024
Subjective — but not objective — olfactory improvements in patients who underwent endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps were maintained up to 6 […]
September 30, 2024
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation. […]
September 30, 2024
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]
September 30, 2024
Color Additives Approved for Use in Medical DevicesPart 73, Subpart D: Color additives exempt from batch certification 21 CFR Section Straight Color Year(2)Approved Uses and Restrictions […]
September 30, 2024
The American Academy of Pediatrics (AAP) published its first clinical practical guidelines on opioid prescriptions for children with acute pain, outlining 12 evidence-based recommendations for safely […]
September 30, 2024
On This Page Date: March 5, 2024 Time: 9:00 AM – 3:30 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]