Investigational New Drug (IND) Application
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of…
CSL Behring – 716297 – 09/09/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Mericon Industries, Inc. – 692733 – 07/17/2025
Unapproved New Drugs/Misbranded
Columbia Cosmetics Manufacturing Inc. – 710885 – 09/11/2025
CGMP/Finished Pharmaceuticals/Adulterated
Blue Forest Farms, LLC – 711990 – 09/11/2025
Adulterated Human Foods/Misbranded
Yangzhou Yulou Paper Products Co., Ltd. – 710907 – 09/09/2025
CGMP/Finished Pharmaceuticals/Adulterated
Disseminated Coccidioidomycosis: Developing Drugs for Treatment
Disseminated Coccidioidomycosis: Developing Drugs for Treatment
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment
Erosive Esophagitis: Developing Drugs for Treatment
Erosive Esophagitis: Developing Drugs for Treatment
Clostebol Metabolism by Different Routes of Administration: Selection of Diagnostic Urinary Markers
The metabolism of clostebol after oral and transdermal applications was described. Ten metabolites were detected after oral administration (M1–M10), but…