Solutions Circle: US Combination Products Updates: What You Need to Know!

Description: In September 2022 FDA issued the final "Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act."
FDA's Combination Product GMP/QMS requirements were finalized back in 2013. The 2016 US Cures Act required FDA to develop a list identifying types of combination products and manufacturing processes for which “good manufacturing processes” may be adopted that vary from the requirements set forth in 21 CFR § 4.4, or that FDA proposes can satisfy the requirements in § 4.4 through “alternative or streamlined mechanisms." Section 4.4 outlines how manufacturers of single-entity and co-packaged combination products can demonstrate compliance with applicable CGMP requirements, including through implementation of a streamlined approach to meet the requirements of both the drug CGMP and the device quality system (QS) regulation. Learn the practical approach that can be utilized for US FDA and mimicked in other global jurisdictions.

* One lucky attendee will receive a copy of RAPS International Combination Products book.