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THE EUROPEAN COMMISION PUBLISHED AN UPDATED GUIDANCE FOR CLINICAL TRIAL REGULATION. The European Commission published an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (#CTR). This is planned for a full launch on 📆 January 31, 2021. The new regulation will replace the clinical trials directive. The revision clarifies that active pharmaceutical ingredients (#APIs) used in investigational medical products do not have [...]

The FDA has issued new draft guidance on the Global Unique Device Identification Database (GUDID). This document was developed to revise “Section III. Policy On Standard Date Formatting, #UDI #Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices” of the 2020 UDI Compliance Policy Guidance. The draft guidance explains there are certain class I devices that are considered consumer health products for which FDA [...]

EMPLOYERS SHUTTING OUT PAYERS TO WORK DIRECTLY WITH MEDICAL GROUPS TO TREAT EMPLOYEES VIA BUNDLED SERVICES Emergence and growth of bundled payments in various therapeutic “Centers of Excellence” has occurred to reduce treatment costs for employers and help improve outcomes. Manufacturers must provide evidence - based outcomes for their product to these medical groups who enter into bundled agreements with employers and are no longer beholden to commercial [...]