The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more
The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more
Wage and Hour -
80/20 Rule Still Followed in Some Parts -
The U.S. Department of Labor (DOL) issued guidance doing away with the so-called "80/20 rule" in November 2018. District courts have greeted the new guidance...more
7/11/2019
/ Americans with Disabilities Act (ADA) ,
Auer Deference ,
Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Class Action ,
Department of Labor (DOL) ,
Dietary Supplements ,
Duty to Defend ,
Employer Liability Issues ,
Fair Labor Standards Act (FLSA) ,
FBI ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GrubHub ,
Hiring & Firing ,
Liquor Control Acts ,
New Guidance ,
Price-Fixing ,
Putative Class Actions ,
Securities Litigation ,
Wage and Hour ,
Wine & Alcohol
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells