FDA Issues Final Guidance: Immunogenicity Testing of Therapeutic Protein Products Last week, the FDA released a final guidance document entitled, “Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection”. This final guidance is based on a draft guidance issued in April 2016 and the comments received during the industry
FDA OPERATIONS IN THE MIDST OF US GOVERNMENT SHUTDOWN. With the US Government shutdown-showdown continuing into its 3rd week, we took a closer look at the operations of Food and Drug Administration (FDA) during this period. According to a statement posted on the FDA website, agency operations continue to the extent permitted by law such
If you don’t plan where you are going, you’ll never get there. Once you have conducted a comprehensive reimbursement landscape assessment from the beginning and not before launch, it is critical to develop a reimbursement roadmap. This document is a visual, month-by-month plan for action for both the financial and operational aspects of the business
Possible Major Changes to 510(k) Program A 510(k) premarket submission is the most commonly used pathway to obtain an FDA market clearance for new medical devices. The essence of the 510(k) process is a demonstration of substantial equivalence (that is a device to be marketed is at least as safe and effective as a legally marketed
Environmental scanning of the reimbursement landscape, also known as reimbursement assessment, is a process that collects information on trends and priorities that impact or influence your medical device’s success in the marketplace. Performing an initial reimbursement assessment is important because it provides a baseline analysis of potential reimbursement gaps, risks, and opportunities for new medical
REMINDER: Annual Blanket No Changes Certification of DRUG Product Listing This is a reminder regarding the FDA’s recent drug certification requirements. Under the FDA’s new drug certification requirements, products that were not initially listed or updated during 2018 must be certified that their previously submitted drug listing information has not been changed. The product listing certification
No matter how hard it is to manufacture a safe and efficacious medical device, it is not going to generate the anticipated revenues unless it can be properly reimbursed by insurers. While considerable time, effort and expense are required to successfully carry out a reimbursement strategy, such a plan is essential to assuring a favorable
Common Mistakes Medical Device Manufacturers Make Today’s economic healthcare environment has created overwhelming reimbursement challenges. The situation is frequently complex and the stakes are high. Companies need not wait for FDA approval before addressing reimbursement issues which they should begin early in the medical device’s development. Putting reimbursement on the back burner until after launch
FDA Food Facility Registration Renewal Period!! Next week, on October 1, 2018, the FDA’s Biennial Registration Renewal Period begins for 2018. Food facilities are required to register with the FDA and renew their registrations between October 1 and December 31 every year as specified under section 415 of the FD&C Act. Food facilities that were
Quality in 510(k) “Quik” Review Program Pilot. On September 6th, the FDA launched the Quality in 510(k) “Quick” Review Program pilot. This program is expected to help manufacturers simplify the premarket notification submission process for certain moderate-risk medical devices. The pilot will also evaluate whether the FDA’s eSubmitter software will result in more organized submissions,
mdi Consultants