The U.S. Food and Drug Administration (FDA) recently completed its first pre-market consultation for a human food made from cultured animal cells and issued a letter stating it had no further questions regarding the...more
On Friday, 16 April 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed modified language for its new regulation on the warning...more
4/21/2021
/ Amended Regulation ,
Food Manufacturers ,
OEHHA ,
Proposition 65 ,
Public Comment ,
Regulatory Agenda ,
Regulatory Requirements ,
Supply Chain ,
Toxic Chemicals ,
Toxic Exposure ,
Warning Labels
On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...more
3/9/2021
/ Baby Products ,
Children's Products ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Hazardous Substances ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Toxic Chemicals
A lawsuit filed yesterday by the California Chamber of Commerce challenges the legality of Proposition 65 warnings on foods that contain acrylamide. The Complaint, which named the Attorney General of the State of California...more
10/9/2019
/ Cancer ,
Chamber of Commerce ,
First Amendment ,
Food Labeling ,
Injunctive Relief ,
OEHHA ,
Proposition 65 ,
Public Health ,
Regulatory Requirements ,
Retail Market ,
State and Local Government ,
Toxic Chemicals ,
Toxic Exposure ,
Warning Labels
The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more
5/21/2019
/ Biopharmaceutical ,
Biotechnology ,
CGMP ,
China ,
Drug Pricing ,
Generic Drugs ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more
12/11/2018
/ China ,
Competitive Bidding ,
Drug Pricing ,
Generic Drugs ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Research and Development
On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more
10/30/2018
/ Additive Manufacturing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Supply ,
Proposition 65 ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Toxic Exposure