The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more
9/1/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Supply Chain ,
Tracking Systems
The Food and Drug Administration (FDA) recently conducted two online studies concerning comprehension of direct-to-consumer (DTC) prescription oncology drug advertising. The research suggests that consumers may have...more
With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more
In a case watched by companies that offered and sold digital assets Federal District Court Judge Paul Barbadoro recently granted summary judgment for the Securities and Exchange Commission (“SEC”) against LBRY, Inc. This case...more
In the wake of the LUNA-UST collapse in which the value of UST and LUNA crashed over 99 percent over a period of days due price manipulation of the algorithmic stablecoin, the Federal Reserve and other regulators have become...more
6/10/2022
/ Blockchain ,
Cryptocurrency ,
Digital Assets ,
Digital Currency ,
Financial Products ,
FinTech ,
Investment Opportunities ,
NYDFS ,
Price Manipulation ,
Regulatory Agenda ,
Stablecoins
As the U.S. Securities and Exchange Commission (“SEC”) continues to step up its enforcement concerning cryptocurrencies, U.S.-based exchanges should take note when conducting due diligence concerning tokens to list for...more
5/24/2022
/ Cryptocurrency ,
Digital Currency ,
Due Diligence ,
Enforcement Actions ,
Enforcement Priorities ,
Financial Fraud ,
Financial Transactions ,
Initial Coin Offering (ICOs) ,
Investment Fraud ,
Securities and Exchange Commission (SEC) ,
Token Sales
In its just-released Financial Stability Report, the Board of Governors of the Federal Reserve System reveals that it has its eye on stablecoins, which now amount to more than $180 billion in the cryptocurrency market. The...more
The SEC recently doubled the size of its Crypto Assets and Cyber Unit. Since its inception in 2017, the SEC’s Crypto Assets and Cyber Unit has launched more than 80 investigations resulting in over $2 billion in monetary...more
5/11/2022
/ Bitcoin Mining ,
Cryptocurrency ,
Decentralized Finance (DeFi) ,
Digital Currency ,
Enforcement Actions ,
Enforcement Guidance ,
Financial Transactions ,
Non-Fungible Tokens (NFTs) ,
NVIDIA ,
Regulatory Agenda ,
Regulatory Oversight ,
Stablecoins ,
Virtual Currency