FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene therapies (“CGTs”):...more
11/7/2025
/ Biotechnology ,
Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Draft Guidance ,
Fast Track Process ,
Food and Drug Administration (FDA) ,
Innovation ,
Life Sciences ,
New Guidance ,
Orphan Drugs ,
PDUFA ,
Pharmaceutical Industry ,
Real World Evidence ,
Regenerative Medicine ,
Regulatory Requirements
In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray’s life sciences regulatory and compliance practice group, are joined by Kellie Combs, partner and chair of Ropes & Gray’s life...more
On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) issued a Press Release announcing a “crackdown on deceptive drug advertising.” Concurrently, the U.S. Department of Health and Human Services (“HHS”)...more
9/15/2025
/ Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Enforcement Actions ,
False Advertising ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Reform ,
Rulemaking Process ,
Trump Administration
Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to...more
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
1/22/2025
/ Clinical Trials ,
Draft Guidance ,
Drug Safety ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
1/14/2025
/ Advertising ,
Compliance ,
Enforcement Actions ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Marketing ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more