Pre-Approval Program
For the preapproval program, OC serves as a communication hub between CDER review divisions and Office of Regulatory Affairs (ORA) inspectors. When establishments are named in new drug applications (NDA) and generic drug applications (ANDA), the names and contact information are sent to OC. Based on available information, OC conducts an initial cGMP evaluation of establishments to determine if the application or product submitted meets product specific criteria. OC then sends both domestic and foreign site field investigator requests to conduct inspections to ORA and, after reviewing the reports from those inspections, submits recommendations as to whether or not the establishments qualify to be named in an approvable application.
Biologic products have somewhat different regulations. Categories of products that are submitted as biologics license applications (BLA) are therapeutic DNA plasmid products, therapeutic synthetic peptide products of 40 or fewer amino acids, monoclonal antibody products for in vivo use and therapeutic recombinant DNA-derived products. The regulations for these products are covered under the Public Health Services Act, Code of Federal Regulations (CFR) 601.2.