Issue Date: March 1, 1995
Issued by: Center for Drug Evaluation and Research
Topic(s): Investigation & Enforcement,
Status: Final
CPG Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs
Download the Guidance Document
ABOUT US
Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.
