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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

Final Combo Product Guidance Out

Jan 30, 2017, 06:47 AM
News Source Link:
https://www.federalregister.gov/documents/2017/01/11/2017-00411/current-good-manufacturing-practice-requirements-for-combination-products-guidance-for-industry-and
RegulatoryNewsDate:
Jan 27, 2017, 12:39 PM

In early January, the FDA released its final guidance on cGMPs for combination products. The finalized guidance addresses concerns industry had expressed regarding FDA communications related to combination products. In addition, the guidance discusses the role of the lead center and other Agency divisions responsible for cGMP issues for these types of products.

regulatory-news-regions:
  • North America