The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
7/29/2025
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Medicare ,
New Legislation ,
One Big Beautiful Bill Act ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Trump Administration
Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....more
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more
A New York Senate bill seeks to amend multiple state laws impacting food and beverage advertising to expand the scope of factors to be considered in determining whether an advertisement is false or misleading....more
3/7/2024
/ Beverage Manufacturers ,
False Advertising ,
Food Labeling ,
Food Manufacturers ,
Food Marketing ,
Food Safety ,
Misleading Impressions ,
New York ,
Popular ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Reform
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
10/31/2023
/ Comment Period ,
FDA Approval ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives.
Starting January 1, 2027, companies manufacturing, selling,...more
10/20/2023
/ Additive Manufacturing ,
California ,
Dietary Supplements ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Products . ,
Food Safety ,
New Legislation ,
Public Health ,
Regulatory Reform ,
State Bans
Introduction -
Effective January 1, 2022, food manufacturers must now comply with the U.S. Department of Agriculture ("USDA")'s National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (the "BE Disclosure Standard"...more
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
2/10/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Supply Chain
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain.
The...more