As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently gathered in Boston to discuss shifting regulatory paradigms under the Trump administration's Food and Drug Administration...more
10/22/2025
/ Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Inspections ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Onshoring ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Trump Administration
As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently met in Boston to discuss shifting regulatory paradigms under the Trump Administration, including trade, drug pricing, and...more
10/21/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
International Trade ,
Life Sciences ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
FDA's release of CRLs for unapproved products does not appear to be limited to situations where the application's existence had been publicly disclosed or acknowledged. Based on our review of those CRLs, along with press...more
At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising key questions about its...more
10/6/2025
/ Abbreviated New Drug Application (ANDA) ,
Comment Period ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Reform ,
Supply Chain
On September 24, 2025, the U.S. Food and Drug Administration (FDA) held a joint town hall with the Partnership for DSCSA Governance (PDG) about the impending expiration of the large dispenser exemption under the Drug Supply...more
10/6/2025
/ Contract Terms ,
Data-Sharing ,
Distributors ,
DSCSA ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Public Meetings ,
Regulatory Requirements ,
Section 340B ,
Supply Chain
Since Congress did not enact an FY 2026 appropriation or a funding extension, the federal government shut down on Wednesday, October 1, at 12:01 a.m. The U.S. Food and Drug Administration (FDA) won't fully shut down along...more
10/1/2025
/ Anti-Deficiency Act ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Trump Administration ,
User Fees
The U.S. Food and Drug Administration (FDA) announced it is changing its approach to direct-to-consumer (DTC) drug advertisements after a directive from a White House Memo instructing FDA and HHS to “to ensure transparency...more
9/12/2025
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Popular ,
Proposed Rules ,
Rulemaking Process ,
Social Media ,
Trump Administration
The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more
9/5/2025
/ Biologics ,
Disclosure Requirements ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Trade Secrets ,
Transparency