Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more
12/9/2025
/ Animal Testing ,
Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Government Agencies ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more
As of October of this year, seven states have passed EPR laws (i.e., California, Colorado, Maine, Maryland, Minnesota, Oregon, and Washington), and more have bills pending in their legislatures. These laws are intended to...more
Last month the Food and Drug Administration (FDA or the Agency) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This interactive dashboard provides access to...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
9/17/2025
/ Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Imports ,
Medical Devices ,
OIRA ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda
Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test...more
8/29/2025
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Layoffs ,
Medical Devices ,
OIRA ,
Pharmaceutical Industry ,
Public Health ,
Reduction of Force ,
Regulatory Agenda ,
Regulatory Reform
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more
7/18/2025
/ Consumer Protection Laws ,
Cosmetics ,
Deregulation ,
Dietary Supplements ,
Enforcement Priorities ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Health and Safety ,
Imports ,
Manufacturers ,
Public Health ,
Regulatory Requirements
On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more
Companies are facing a unique trade market. President Trump has announced various tariffs, including additional tariffs on China, the on-again, off-again tariffs on Canada and Mexico, auto tariffs, steel and aluminum tariffs,...more
4/22/2025
/ Aluminum Sales ,
Automotive Industry ,
B2B Organizations ,
Canada ,
China ,
Contract Termination ,
Contract Terms ,
Force Majeure Clause ,
Mexico ,
Steel Industry ,
Supply Chain ,
Tariffs ,
Termination ,
Trump Administration
On April 10, 2025, the Food and Drug Administration (FDA) released a pre-recorded webinar outlining the updated "healthy" nutrient content claim rule. As we previously discussed, the rule will go into effect on April 28,...more
4/21/2025
/ Compliance Dates ,
Consumer Protection Laws ,
Dietary Supplements ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Government Investigations ,
New Rules ,
Regulatory Requirements ,
State Attorneys General ,
Webinars
On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....more
On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more
On December 19, 2024, the Food and Drug Administration (FDA) announced a final rule updating the definition of the term "healthy" as used in food labeling. Under the rule, manufacturers may use the term "healthy" and similar...more