Advancing Generic Drug Development: Translating Science to Approval 2025 – 10/07/2025
Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee…
www.usaquickmeds.com – 713312 – 08/01/2025
Misbranded and Unapproved New Drugs
Boothwyn Pharmacy LLC – 710247 – 06/09/2025
Unapproved New Animal Drug/Adulterated/Misbranded
Everlaan Organics, Inc. dba Maple Organics – 707956 – 08/11/2025
CGMP/OTC/Unapproved New Drugs/Misbranded
Anhui Hanbon Daily Chemical Co., Ltd. – 708903 – 08/11/2025
CGMP/Finished Pharmaceuticals/Adulterated
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data – 09/18/2025
On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to…
Approaches to Assessment of Overall Survival in Oncology Clinical Trials
Approaches to Assessment of Overall Survival in Oncology Clinical Trials
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
Drug Trials Snapshots: ENFLONSIA
Drug Trials Snapshots: ENFLONSIA