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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

WHG Side-By-Side Summarizes 5 Key Federal Telehealth Bills

It can be hard to keep track of federal telehealth legislation in a sea of legislative and regulatory health care priorities, so the team at Wynne Health Group has made it easy for you. We created a side-by-side (SBS) summarizing five key telehealth bills introduced in the 116th Congress: ECHO Act of 2019; Mental Health Telemedicine Expansion Act; CONNECT for… (Testa, 2/14/20) #Physicians, #Telehealth, #Grants, #Rural Health, #Chronic Diseases, #Mental and Behavioral Health

Request for Information on Vaping Products Associated with Lung Injuries Due April 15

The Food and Drug Administration (FDA) issued a request for information (RFI) related to the use of vaping products that are associated with lung injuries (press release). The FDA has issued this request in response to a Congressional directive to gather information from the public that could help identify and evaluate additional steps the agency could take to address the… (Slifer, 2/14/20) #Food and Drug Administration, #Pediatrics, #Public Health

Committee Leaders Request Extensive Information from UNOS Regarding Oversight of OPTN, Network of OPOs

Senate Finance Chairman Chuck Grassley (R-IA), Ranking Member Ron Wyden (D-OR) and Sens. Todd Young (R-IN) and Ben Cardin (D-MD) cosigned a letter (press release) this week to Brian Shepard, CEO of the United Network for Organ Sharing (UNOS), regarding oversight of the Organ Procurement and Transplantation Network (OPTN) and the 58 organ procurement organizations (OPOs) they monitor. Citing “lapses… (Cowey, 2/13/20) #Program Integrity

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