Rob Lindberg, Ph.D., R.A.C., is the Center's BATON director. He holds a Ph.D. in Physiology and Biophysics. His specialty is microvascular physiology, with emphasis in endothelial function in inflammation, thrombosis and cancer.
Full Biography.
Generic Drugs
Generic pharmaceuticals are also regulated by CDER, through the Office of Generic Drugs. A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Verification of chemical identity of the generic to an approved novel (innovator) drug is a key challenge for developers of generics. The generic drug approval process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness, thus expediting the path to market relative to that of an innovator drug. However, submission of the final approval application (Abbreviated New Drug Application, ANDA) is only allowed once the patent life of the innovator compound has expired.
Biological Drugs
CBER regulates the licensing of:
- Allergenics;
- Blood, blood components (red blood cells, plasma, platelets) and products derived from blood (e.g., clotting factors and immunoglobulins);
- Devices, tests and reagents associated with safeguarding the nation’s blood supply from infectious agents (e.g., HIV);
- Gene therapy products used to replace a patient’s faulty or missing genetic material;
- Human tissues and cellular therapeutics; vaccines;
- Xenotransplantation products (i.e., live animal cells, tissues or organs used to treat human diseases);
- Therapeutic DNA plasmid products;
- Therapeutic synthetic peptide products of 40 or fewer amino acids; and
- Therapeutic recombinant DNA- or RNA-derived products (e.g., antisense oligonucleotides, RNAi).
In 2003, review and regulation of the following types of biological products was transferred from CBER to CDER:
- Monoclonal antibodies for in vivo use;
- Proteins intended for therapeutic use, including cytokines (e.g., interferons), enzymes (e.g., thrombolytics), and other novel proteins, except for those that are specifically assigned to CBER (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, or microorganisms, and recombinant versions of these products;
- Immunomodulators: proteins or peptides that are not antigen-specific (e.g., cytokines, growth factors, chemokines) that are intended to treat disease by inhibiting or modifying a pre-existing immune response, and proteins or peptides intended to act in antigen-specific fashion to treat or prevent autoimmune diseases by inhibiting or modifying pre-existing immune responses; and
- Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of cells in vivo.
In contrast to small molecule (pharmaceutical) drugs that are chemically synthesized and whose structure is known, most biologics are complex mixtures that are not easily fully identified or fully characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination, which necessitates the use aseptic principles from initial manufacturing steps.
The process for attaining marketing approval for biological therapeutics parallels that for pharmaceutical drugs, although final application for approval is made via a Biologics License Application (BLA) rather than an NDA. At present, the concept of ‘generic biologicals” is not defined by the FDA and is the source of much discussion (and contention) amongst the biotechnology community.