FDA:- Adverse Event Reporting for Combination Products
The FDA has published two key documents, these two guidance documents provide significant guidance to manufacturers of combination products. The guidance clarifies the regulations in terms of the provisions requiring applicants to submit additional types of adverse event and product problem reports to the FDA. The regulations also require mandatory sharing of adverse event information between companies manufacturing the individual constituent parts of a combination product. Since these guidance documents have been recently published it is critical for manufacturers to fully understand their implications and individual applicant responsibilities under the post-marketing provisions in terms of how the regulations are clarified and interpreted. In this webinar expert speaker Charles H. Paul will defines the post-marketing safety reporting for combination product and specifies and clarifies the FDAs policy for combination product post-marketing safety reportin...