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CBER carries out a wide range of regulatory activities during the "life cycle" of biological products.
- Inspections of manufacturing facilities are conducted to assess whether biological products are made in compliance with the appropriate laws and regulations. Inspections are conducted before products are licensed or certain changes approved (pre-license and pre-approved) and once approved, routine GMP inspections are conducted periodically to ensure continued compliance. CBER utilizes an integrated approach to the managed review for licensed biological products by performing the pre-approval/pre-license inspections (PAI/PLI) as part of the complete review of the marketing submissions. CBER staff conducts these inspections. CBER product specialists and/or ORA investigators may participate as a member of the PAI/PLI inspection team.
- CBER's Bioresearch Monitoring (BIMO) program includes on-site inspections of clinical investigators, sponsors / monitors, non-clinical testing labs for good laboratory practices, and institutional review boards (IRB). These inspections assess the protection of the rights, safety, and welfare of human research subjects, and verify the quality and integrity of data submitted to us. We also conduct inspections to investigate complaints from subjects who participated in clinical trials.
CBER continues to monitor the safety, purity and potency of licensed biological products after approval, as well as the safety of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). Examples of these monitoring activities include:
- Routine GMP inspections of our licensed biological drugs and devices are performed by Team Biologics with participation from CBER product specialists. Investigators from FDA's Office of Regulatory Affairs (ORA) conduct routine inspections of establishments that manufacture blood and blood products, source plasma and Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) according to established Compliance Programs.
- Analysis of Biological Product Deviation Reports (BPDRs) and HCT/P Deviation Reports, which can provide an early warning of problems in manufacturing. Manufacturers are required to report certain deviations in manufacturing of distributed licensed biological products, blood components, and HCT/Ps. Information from BPDRs is used to identify possible recall situations. The information is also used to identify the need for guidance and training for industry and FDA field investigators.
- CBER personnel monitor investigations into transfusion and donation related fatalities and complaints from consumers and other sources.
- In addition to required reporting by manufacturers, health professionals and members of the public are encouraged to report adverse events or reactions with biological products to FDA's MedWatch and, for vaccines, to the Vaccine Adverse Event Reporting System (VAERS).
- CBER personnel evaluate the health hazard associated with biological products that are voluntarily recalled or withdrawn from the market by manufacturers. CBER posts information on these actions when it is received from the manufacturer and in the weekly FDA Enforcement Report once the recall is evaluated for health hazard.
- It is FDA's policy to help prevent or alleviate shortages primarily of medically necessary drug products, since these can have significant public health consequences. A drug shortage may involve either an actual or a potential shortage of a drug product. Reports and publicized consumer information related to biological product shortages are monitored, and product shortage information is made available on the web.
- When a manufacturer is not in compliance with applicable laws and regulations, FDA may take a variety of regulatory actions. Advisory actions inform the manufacturer of violations that should be promptly corrected. Administrative or judicial actions may be considered when violations represent a significant public health risk. These actions include suspension or revocation of biologics licenses or civil and criminal penalties. When a clinical investigator is conducting studies of biologics products in a manner that poses an undue risk to safety of the human subjects, CBER can take specific enforcement actions such as disqualification or debarment. CBER also monitors the Internet and advises website owners that selling unlicensed or unapproved products in the United States is a prohibited act.
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