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New Guidance for Combination Products

MassMEDIC

Mar
16
2017

Date: March 16, 2017

Time: 8:00AM

Location: Waltham, MA

Topics

  • Combination Products – Overview
     

As interest in developing innovative combination products continues to grow, industry has turned to FDA for additional guidance on how to navigate the differing policies and review procedures of the FDA Centers that regulate the product components and how to receive timely responses on issues such as requests for designation, pre-submission guidance, and primary jurisdiction.

This program will also focus on several recent new guidances and rules intended to simplify the process as well as on new and ongoing initiatives at FDA and reactions from industry.

Speakers

Linda D. Bentley has extensive knowledge of the FDA and other agencies that regulate the Pharmaceutical, Biotechnology, and MedTech, Tools, and Devices fields. At Mintz, she uses her knowledge of technology, regulatory requirements, clinical trials, and health care to advise clients.