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
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
1/22/2025
/ Administrative Procedure Act ,
Consent Decrees ,
Constitutional Challenges ,
Corporate Integrity Agreement ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Life Sciences ,
Medical Devices ,
Opioid ,
OxyContin ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Purdue Pharma ,
Qui Tam ,
Regulatory Requirements ,
Stem cells ,
Transparency
On this episode of Ropes & Gray’s podcast series Controlling Opinions, Josh Oyster, a partner in the life sciences regulatory and compliance practice group, is joined by colleagues Andrew O’Connor, a litigation and...more
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