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
We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact...more
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications -
On 28 March China's National Medical Products Administration (NMPA) published a list of an...more
Read the latest news on antitrust, competition and economic regulation (ACER) in this Winter's edition of our quarterly ACER newsletter.
...more
4/3/2019
/ Antitrust Provisions ,
Bid Rigging ,
CFIUS ,
Economic Development ,
EU ,
Federal Trade Commission (FTC) ,
Foreign Direct Investment ,
Government Shutdown ,
Hold-Separate Remedies ,
Merger Controls ,
No-Poaching ,
Pharmaceutical Patents ,
Public Procurement Policies ,
Regulatory Standards ,
South Africa ,
UK Competition and Markets Authority (CMA)
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
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
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
Last week, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed an amendment to the existing regulation requiring: (1) the average...more
Last Friday, China announced a second round of American products that could be subject to retaliatory tariffs between 10 to 25 percent. 1/ The proposed list would target $60 billion worth of additional United States...more
8/14/2018
/ China ,
Exports ,
Farms ,
Food Supply ,
Imports ,
Supply Chain ,
Tariffs ,
Trade Relations ,
Trade Retaliation ,
Trump Administration ,
US Trade Policies
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
A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning...more
8/6/2018
/ Appeals ,
Beverage Manufacturers ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
OEHHA ,
Preemption ,
Proposition 65 ,
Reversal ,
Toxic Chemicals ,
Warning Labels
On Friday, June 15th, the California Office of Environmental Health Hazard Assessment (OEHHA) announced a proposed regulation clarifying that exposures to Proposition 65 chemicals in coffee do not pose a significant cancer...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
Food companies and retailers doing business in California should take note of the recent proposed statement of decision in the case challenging the coffee industry’s failure to warn of the presence of acrylamide in coffee...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
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good...more
The Federal Trade Commission (FTC) Bureau of Consumer Protection is where the action is when it comes to identifying current and future trends related to consumer protection. Bureau actions are closely watched to identify...more
2/26/2018
/ Advertising ,
Celebrity Endorsements ,
Consumer Protection Laws ,
Disclosure Requirements ,
Endorsements ,
Federal Trade Commission (FTC) ,
FTC Endorsement Guidelines ,
Influencers ,
Instagram ,
Marketing ,
Online Endorsements ,
Snapchat ,
Social Media ,
Unfair or Deceptive Trade Practices