Vaccine Adjuvants- FDA & CDC
The patient safety and efficacy of adjuvants are highly required as the vaccines are one of the lifesaving agents. Therefore, the FDA and CDC rules regarding the vaccine adjuvants are highly essential during vaccine formulation and manufacturing processes. CBER of FDA is responsible for vaccine regulation in the United States. Vaccine development process follows the same pathway as for drugs and other pharmaceutical agents. A sponsor must submit the Investigational New Drug application (IND) to FDA. The IND describes about the vaccine, quality control tests for release, and its method of manufacture. After the successful completion of all three phases of clinical development the Biologics License Application (BLA) are submitted. After getting the permission form FDA and CDC a vaccine may be marketed.