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Policy Hub

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Final Rule Issued to Amend Definition of Biological Product; Aids Transition for Insulin as a Biologic

The Food and Drug Administration (FDA) issued a final rule to amend the definition of “biological product” to incorporate statutory changes and to provide an interpretation for the definition of  a “protein.” In the accompanying press release, the FDA notes this final rule will ensure a smooth regulatory transition aimed at increasing patient access to insulin products and other biological… (Slifer, 2/20/20) #Biosimilars, #Food and Drug Administration, #Prescription Drugs

ONDCP, CDC Announce FY 2020 Drug-Free Communities Support Program Grant Opportunity; Due April 3

The White House Office of National Drug Control Policy (ONDCP), in partnership with the Centers for Disease Control and Prevention (CDC), recently issued a Notice of Funding Opportunity Announcement (FOA) for the fiscal year 2020 Drug-Free Communities (DFC) Support Program. The FOA is available to new coalitions (year 1 applicants) and competing continuations (year 6 applicants). The DFC Support Program… (Llamas, 2/19/20) #Mental and Behavioral Health, #Hospitals, #Pediatrics, #Physicians

Agency Solicits Comments on Potential New Poverty Measures; Comments Due. April 14

The Office of Management and Budget (OMB) recently released a solicitation for comments on questions posed by the Interagency Technical Working Group on Evaluating Alternative Measures of Poverty (Working Group). In brief, the Working Group is considering the development of additional measures for poverty, beyond the current Official Poverty Measure (OPM) and Supplemental Poverty Measure (SPM). As OMB notes, the… (LaRosa, 2/14/20) #Health Equity, #Social Determinants of Health