Increased public health interest in “forever chemicals” is leading to a new, complex regulatory landscape for manufacturers, distributors, and retailers of foods, cosmetics, and other consumer products. As FDA and other...more
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more
Executive Summary -
On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
11/10/2023
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Vaccinations
On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie...more
As of June 21, 2023, two food companies have received a grant of inspection from the U.S. Department of Agriculture (USDA) for their cell-cultivated chicken. This means the two companies, GOOD Meat (a division of Eat Just,...more
The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol...more
6/2/2023
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Decriminalization of Marijuana ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Medical Foods ,
Plant Based Products ,
Regulatory Agenda ,
Retail Market
I. WHY THIS CASE MADE THE LIST -
A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
5/24/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CEOs ,
CLIA ,
COOs ,
Corporate Crimes ,
Corporate Executives ,
Corporate Governance ,
Corporate Misconduct ,
Corporate Officers ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
FBI ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Patients ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Wire Fraud
On the heels of a January 2023 statement released by the FDA expressing the need for a new regulatory pathway for cannabidiol products, two CBD-related bills were reintroduced in the House of Representatives on March 17,...more
The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more
Key Takeaways:
▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more
2/14/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Standards ,
Supply Chain ,
Third-Party