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A comprehensive overview of the fda's regulatory framework for biological products, including hormones, vaccines, and gene therapy. It outlines the key regulations, application processes, and review procedures involved in bringing these products to market. The document also highlights the differences between biologics and small molecule drugs, emphasizing the unique challenges and considerations associated with biologics development.
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US Regulation for Biologics and Biosimilars Definition: Biologics: Public health service (PHS) act defined as “ Biologics are single or combination of virus, Therapeutic serum, Toxin, Antitoxin, Vaccine, Blood, Blood component or Derivatives, Allergenic product, or Analogues product used for treatment, diagnosis, and prevention of disease condition.
Public Health Service Act (PHSA) Act was started in 1944. The act established the federal government's quarantine authority for the first time. It gave the United States Public Health Service responsibility for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the United States. CBER (center for biological evaluation and research) AND CDER (center for drug evaluation and research) It works under FDA and Public Health Service Act (PHSA). The main objective of CBER is to protect and enhance public health by regulating biological products, vaccines, tissue, and gene therapy product. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by CDER. The following product will be 1) regulated by CBER such as- a) Gene and gene product. b) The allergenic extract is used for the diagnosis and treatment of allergies. c) Venom, antitoxin, and antivenin. d) Blood, several blood products, and the device used for collection, testing, and processing of blood. e) Xenotransplant
f) Human cell, tissue or cellular, and tissue base product
f. Explanation of the patient observation, measurement, and test to be used. g. The clinical procedure, Laboratory test, and monitoring to be used in minimizing patient risk. h. All information such as the name, address, and credentials of the principal investigator and co- investigator. i. Location and Description of the clinical research facilities to be used. j. Approval of the authorized IR. The application Review process of IND After review by CDER or CBER, CDR, the application is sent to the document control center which is responsible for the review of the application. Acknowledgment letter is sent to the applicant and the project manager is assigned to coordinate the NDA review process. CD is responsible for the distribution of various copies of IND to the different divisions for evaluation. The project manager performs the initial screening of application are refused for feeling. If the concern is found, then a deficiency letter is sent to the applicant. NDA (New Drug Application)
NDA and BLA application is required to market a new drug and biologics product. NDA is used by CDER for the market to drug products. BLA is used by CBER for the market to biologics products. The review and approval of NDA are based on safety, efficacy, according to detailed reports of clinical trials. The pre- NDA meeting between the sponsor and FDA to discuss the content and format of the NDA. The purpose and main mission of NDA are to gain permission to market the drug and biologics. NDA has a specialized review team of highly qualified experts. The review team will decide to approve or disapprove the NDA. Classifies new drug applications according to the type of drug being submitted and its intended use:
g. Conclusion of studies include safety and effectiveness of the device h. Reference to any performance standard followed i. Labeling j. Result of the non-clinical lab study k. Result of clinical studies on human patients l. Financial certification. 510K The 510k process is rapid, flexible, and adaptable to many devices. The main goal of 510k is “Demonstration of sustained to a device that was on the US market before May 28, 1976, or to a device that has already gone through 510k clearance process”. The device is successfully gone through the 510k process are called “510k cleared”. Types of 510k: There are four main types of 510k are as follows- a) Traditional 510k- Traditional 510k filed when sponsor developed a similar device or equivalence to a device that has been cleared through the 510k processor was already in the market before the 1976 med ical Device Amendments were sighed on May 26, 1976. b) Abbreviated 510k - This 510k is similar to the traditional 510k in function. A sponsor can choose to comply with FDA accepted standards during the testing process. A declaration of conformance included in the 510k, stating that the device meets the specification in the reference standard. c) Special 510k - A special 510k is submitted when a sponsor has made some modification in her/his device and has not added a new indication for use. d) De Novo 510k - The De Novo 510k is a 510k without a predicate device. It is not a commonly used path, but in some circumstances, it is appropriate. Content of 510k:
a) The cover sheet (FDA form 3514). b) The cover letters c) The table of content d) User fee information e) Statement of substantial equivalence f) Labeling g) Advertising and promotional material. h) Comparative information.