On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
7/17/2025
/ Compliance ,
Disclosure Requirements ,
Drug Pricing ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Transparency
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