The attribution of responsibility for the review to one centre does not preclue the participation of the other centre in the review. In clinical indications that can be reviewed clinically at both centres, the centres agree to ensure consistency in clinical assessment and outcome evaluation standards, by working together to develop relevant guidelines, guidelines and regulations, and by continuing to hold staff-level working meetings to discuss clinical issues. Regular intercenter meetings on products to treat AIDS and cancer continue and include specific planning for the coordinated review of pending applications. Centres with handsets and organic products are CBER and CDRH. If CBER is responsible for a combined product, the Intercenter agreement allows CDRH to consult on the safety, efficiency and durability of the components of that product. Similarly, CDRH may consult CBER on the biological components of the combined products under its jurisdiction. In general, combined products for direct therapeutic use are regulated by CDRH. Products containing components that collect, separate or process blood or blood products, similar products or cellular biological products, including cell and tissue implants, indefamined cells and encapsulated tissue cells, are regulated by CBER. CDER is the leading regulatory centre for fda-regulated human drugs under the supervision of the Federal Human Use Drugs Act (FD-C).
Drugs are defined in Section 201 (g) of the FD-C Act. CBER is the main regulatory centre for biologics. Organic products are regulated and defined under the supervision of Section 351 of the Public Health Services (PHS) Act and in 21 CFR 600.3. Biologics are also medicines or medical devices within the meaning of the FD C. This agreement replaces all previous agreements. In some cases (for example. B allergy and dermatology or clinical immunology and GI), clinical indication can be a hybrid between several areas. In these cases, a medical control team may be made up of appropriate experts from both centres. As you probably noticed, the definition of drugs and biological overlap and created confusion about the center that would observe biologic drugs that act as drugs. The FDA`s guideline is to check each product on a case-by-case basis to determine the monitoring center, which is generally based on the primary mode of action of the drug (PMoA). In 1991, CBER-CDER established an Inter-Centre Agreement (ICA) to try to clarify the regulation of biologist products by indicating which centres should regulate which products.
It also specifies the products combined in this agreement. In addition, in 2003, the FDA transferred some of the therapeutic biological products (well-characterized proteins) from CBER to CDER in the hope of strengthening production areas.