By Fran DeGrazio, Vice President, Scientific Affairs and Technical Services, West Pharmaceutical Services, Inc.
Sometimes patients need to use combination products and delivery systems to deal with a chronic condition or to ease an acute condition. While many of these types of products have been available for years, recent FDA and ICH guidelines have clarified expectations from both a developmental and commercialization standpoint. These clarifications have led to increased regulatory expectations, resulting in new and increased challenges for manufacturers. To ensure compliance with these regulations and overcome challenges, it is essential to remain familiar with the changing regulations, and to receive additional insights from various sources.