China recently announced two revised decrees that, once implemented, would impose substantial new requirements for food and beverage companies that export to China. These regulations are as follows: In particular, with some...more
6/15/2021
/ Beverage Manufacturers ,
China ,
Customs ,
Exports ,
Food & Drug Regulations ,
Food Manufacturers ,
Food Supply ,
Foreign Suppliers ,
Imports ,
International Trade ,
Registration Requirement ,
Regulatory Oversight ,
Regulatory Standards ,
Suppliers
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
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
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
On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum