As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
1/7/2025
/ Classification ,
Clinical Trials ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Institutional Review Board (IRB) ,
International Harmonization ,
Investigations ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Office for Human Research Protections (OHRP) ,
Prescription Drugs ,
SACHRP
Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more
11/5/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fixed Price ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Inpatient Prospective Payment System (IPPS) ,
Loper Bright Enterprises v Raimondo ,
Medicaid Drug Rebate Program ,
Medicare ,
ONC ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Public Health Emergency ,
Reimbursements ,
SEC v Jarkesy ,
Statutory Interpretation ,
Telehealth