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By Holly Brevig, Ph.D. With a Drug Supply Chain Security Act deadline looming, the FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product. By Each month, works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers.
By Fran DeGrazio, Strategic Parenteral Solutions LLC The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances for this segment of the industry.
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.