Why Post Licensure Requirements For Recordkeeping And...

11. Please describe two (and only two) reasons why post-licensure requirements for recordkeeping and reporting are particularly important for product designated as biologics Post-approval requirements for recordkeeping and reporting are extremely helpful to monitor the activity of the product. Moreover, the product records are kept in order to constantly control the safety and effectiveness of the product. Post-licensure recordkeeping establish the database with all related documents including adverse events reports, additional clinical trials data, changes in labeling of the products and etc. 12. Please describe two (and only two) types of manufacturing arrangements that are permitted by FDA for biologic products There are two types of manufacturing agreements for the biologics – sole manufacturing and cooperative manufacturing agreements. Sole manufacturing concept implies that all manufacturing operations are conducted at a single site. This type of manufacturing is not the most common arrangement today. The biologic manufacturers that choose to work under the sole manufacturing model prefer to use either multi-use facilities or pilot plants. Multi-use facilities and pilot plans permit production of several products. Cooperative manufacturing concept has four additional types of manufacturing arrangement: †¢ Short supply arrangement The most limited manufacturing arrangement. The manufacturer can use another manufacturing site when there is deficiency of the materialShow MoreRelatedMedicare Policy Analysis447966 Words   |  1792 PagesA—General Standards Subtitle B—Standards Guaranteeing Access to Affordable Coverage Subtitle C—Standards Guaranteeing Access to Essential Benefits Subtitle D—Additional Consumer Protections Subtitle E—Governance Subtitle F—Relation to Other Requirements; Miscellaneous TITLE III—HEALTH INSURANCE EXCHANGE AND RELATED PROVISIONS Subtitle A—Health Insurance Exchange Subtitle B—Public Health Insurance Option Subtitle C—Individual Affordability Credits TITLE IV—SHARED RESPONSIBILITY Subtitle A—Individual