Guidance Documents for Rare Disease Drug Development
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Patient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.Creative Essences, Inc. – 710658 – 09/25/2025
CGMP/Finished Pharmaceuticals/AdulteratedBaxter Oncology GmbH – 08/27/2024
Baxter Oncology GmbH – 08/27/2024. Country: Germany. Record Type: 483GO Raw LLC. Expands Voluntary Recall of Quest Diet Cat Food Products Due to Low Thiamine Levels and Enacts Stop Sale of All Quest Products
Cottonwood Heights, Utah (February 26, 2026) Go Raw LLC is expanding its February 17, 2026, voluntary recall of a freeze-dried product to add two lots of select Quest Cat Food Chicken Recipe frozen products due to potentially low levels of thiamine (Vitamin B1).
The two lots of Quest Cat Food ChickeFDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery or for whom surgery is not advisable. This is the first approval forLiquidCapsule Manufacturing, LLC – 717069 – 12/19/2025
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