Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway
Program landing page
Evaluating the Testosterone‐to‐Luteinizing Hormone Ratio in Male Anti‐Doping Serum Samples: Results From a Transdermal Testosterone Administration Trial and Field Collected Samples
Practicality of serum T/LH ratio was investigated in the context of a transdermal testosterone administration study and a field study…
Health and Natural Beauty USA Corp. – 700187 – 07/28/2025
CGMP/Finished Pharmaceuticals/Adulterated
GDUFA III Reauthorization
Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has…
GDUFA IV: Fiscal Years 2028 – 2032
Information related to FDA’s preparation for the fourth reauthorization of GDUFA will be hosted on this page as it becomes…
Generic Drugs – Specific Labeling Resources
Generic Drugs – Specific Labeling Resources
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – 04/10/2024
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access
Equine Metabolism of Voxelotor and Its Impact on Hematological Indices: A Doping Control Perspective
Voxelotor, a sickle cell drug now banned by WADA, was studied in Thoroughbred horses after oral dosing. LC-HRMS identified 35…
FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma
On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of…
Replacing and Reducing Animal Testing at CDER
It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies,…