Titles
- Billions in estimated Medicare Advantage payments from diagnoses reported only on health risk assessments raise concerns1
- Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff1
- Biological product deviation reporting for blood and plasma establishments1
- Bipartisan Rx for America's health care: a practical path to reform1
- Black Lung Benefits Program: oversight is needed to address trust fund solvency strained by bankruptcies : testimony before the Committee on Education and Labor, Subcommittee on Workforce Protections, House of Representatives1
- Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff1
- Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff1
- CMS should pursue strategies to increase the number of at-risk beneficiaries acquiring naloxone through Medicaid1
- CMS’s encounter data lack essential information that Medicare Advantage organizations have the ability to collect1
- COVID-19 intensifies nursing home workforce challenges1
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- COVID-19: brief update on initial federal response to the pandemic : report to Congress1
- COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees1
- COVID-19: federal efforts could be strengthened by timely and concerted actions : report to Congressional committees1
- COVID-19: opportunities to improve federal response and recovery efforts : report to the Congress1
- COVID-19: urgent actions needed to better ensure an effective federal response : report to Congressional committees1
- Cancer clinical trial eligibility criteria: brain metastases1
- Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs1
- Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections1