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Jul 15, 2024 | 
jdsupra.com | Regina DeSantis |Bryant M. Godfrey |Tina Papagiannopoulos
Key Takeaways: FDA released a Revised Draft Guidance document with recommended practices for combatting misinformation online. Firms may wish to issue tailored responsive communications to combat specific instances of internet-based misinformation as defined by FDA. FDA establishes an enforcement policy regarding tailored responsive communications which must fall within an outlined scope and include certain disclosures and disclaimers.
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Jul 3, 2024 | 
jdsupra.com | Thomas Barker |Regina DeSantis |Marilyn Icsman
Key Takeaways: On June 28, 2024, in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce (“Loper Bright”), the Supreme Court struck down the doctrine of Chevron deference, ending four decades of judicial deference to agency interpretations of ambiguous statutes. Deference to federal agencies will now be permitted only when Congress has expressly delegated such authority—and even then only as applied to factual determinations.
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May 14, 2024 | 
jdsupra.com | Jesse Alderman |Haider Andazola |Regina DeSantis
On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More specifically, the Department of Justice (DOJ), which has authority over the DEA, submitted a formal rescheduling recommendation to the White House following an August 2023 recommendation from the Department of Health and Human Services (HHS) to the DEA to reschedule cannabis.
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Apr 30, 2024 | 
mondaq.com | Ross Margulies |Regina DeSantis
On April 10, 2024, CMS published the fiscal year (FY) 2025
Medicare Hospital Inpatient Prospective Payment Systems (IPPS)
Proposed Rule, which contains several key proposals that could
provide additional benefits for manufacturers seeking to apply for
New Technology Add-on Payments (NTAP) for their technologies.
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Apr 25, 2024 | 
jdsupra.com | Regina DeSantis |Ross Margulies
Key Takeaways: On April 10, 2024, CMS published the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule, which contains several key proposals that could provide additional benefits for manufacturers seeking to apply for New Technology Add-on Payments (NTAP) for their technologies.
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Oct 11, 2023 | 
mondaq.com | Regina DeSantis
As readers of this blog are well aware, the uncertainty
surrounding the legality and enforceability of Massachusetts'
"Community Impact Fees," most recently addressed by
An Act Relative to Equity in the Cannabis Industry
("the Act"), which took effect in November of 2022, has
led to much consternation in the industry and, in several cases,
lawsuits by operators against their host communities. One of the
latest of these lawsuits was filed by Pittsfield-based Berkshire
Roots.
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Oct 10, 2023 | 
lexblog.com | Regina DeSantis
As readers of this blog are well aware, the uncertainty surrounding the legality and enforceability of Massachusetts’ “Community Impact Fees,” most recently addressed by An Act Relative to Equity in the Cannabis Industry (“the Act”), which took effect in November of 2022, has led to much consternation in the industry and, in several cases, lawsuits by operators against their host communities. One of the latest of these lawsuits was filed by Pittsfield-based Berkshire Roots.
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Oct 10, 2023 | 
jdsupra.com | Regina DeSantis
As readers of this blog are well aware, the uncertainty surrounding the legality and enforceability of Massachusetts’ “Community Impact Fees,” most recently addressed by An Act Relative to Equity in the Cannabis Industry (“the Act”), which took effect in November of 2022, has led to much consternation in the industry and, in several cases, lawsuits by operators against their host communities. One of the latest of these lawsuits was filed by Pittsfield-based Berkshire Roots.
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Sep 13, 2023 | 
lexblog.com | Regina DeSantis
On Friday, September 8, the Maryland Cannabis Administration (MCA) Office of Social Equity released additional information for its upcoming initial licensing round, including the social equity verification portal, application timeframe and deadlines, and the number of licenses available per county. The first round of licensing is limited to Social Equity Applicants.
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Apr 8, 2023 | 
lexblog.com | Regina DeSantis
Key Takeaways:Amendments to Maryland House Bill (HB) 556, and its companion Senate Bill (SB) 516, provide clarification on essential provisions for persons or entities interested in participating in the cannabis industry in Maryland. Both bills have crossed over and are expected to quickly pass the other chamber, and once a compromise version passes both chambers, it is expected that Governor Wes Moore (D) will sign into law.
