News & Analysis as of

Applications Regulatory Requirements

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

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In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

Foley Hoag LLP - Energy & Climate Counsel

ORES Releases Draft Siting Rules for Major Renewable and Transmission Projects in New York State

On Wednesday, December 18, 2024, the New York State Office of Renewable Energy Siting and Electric Transmission (“ORES”) issued its much-anticipated draft regulations concerning the environmental review, permitting, and...more

Foley Hoag LLP - Cannabis and the Law

New Jersey Opens Applications for Consumption Lounges

While the pace of adult-use applications in New Jersey has steadied from its initial peak between 2021-2023, a new wave of applications has just opened for consumption lounges in the Garden State. Who May Apply? Any...more

Bass, Berry & Sims PLC

DOD’s Office of Strategic Capital Announces First Notice of Funding Availability

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On September 30, the Department of Defense’s (DOD) Office of Strategic Capital (OSC) announced a notice of funding availability (NOFA) of up to $984 million in loans aiming to support the financing of certain covered...more

Foley Hoag LLP - Cannabis and the Law

New York Promulgates Interim Guidance on Changes of Ownership and License Amendments

The New York Office of Cannabis Management (“OCM”) has promulgated interim guidance identifying how it will address changes of ownership and other license amendments. While many have criticized the OCM for delays in...more

Shipkevich PLLC

Illinois Adopts Model Money Transmission Act in Quest for Money Transmission Regulatory Consistency

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As of August 9, 2024, Illinois joins Maryland, South Dakota, Wisconsin, Kansas, Maine, Vermont, South Carolina, Missouri, and Connecticut as the latest state this year to have enacted legislation or regulations stemming from...more

Gibney Anthony & Flaherty, LLP

New Biden-Harris Administration Parole in Place Spousal Protection Program:  USCIS Will Begin Accepting Applications Starting...

The Department of Homeland Security (DHS) previously announced a new spousal protection policy in keeping with the Biden-Harris administration’s commitment to keep families together....more

Eversheds Sutherland (US) LLP

United States Treasury Department-approved surety bond insurers: Will you be ready to take advantage of the new reduced collateral...

What You Need to Know About the New Classes of Treasury-Authorized Reinsurers in Advance of the August 9, 2024 Implementation Date - As we reported in our June 24, 2024 Legal Briefing, the US Department of the Treasury...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Solar Panel Array: New Hampshire Supreme Court Addresses Zoning Issue

The Supreme Court of New Hampshire (“Supreme Court”) in an April 9th, 2024 Opinion addressed an issue arising out of a proposal to install a solar panel array. See Mojalaki Holdings v. City of Franklin, 2024 N.H. 17 (2024)....more

Woods Rogers

Defense Department’s Proposed CMMC Rule Will Impose New Cybersecurity Requirements on Contractors

Woods Rogers on

The U.S. Department of Defense (DoD) released a proposed rule to implement its Cybersecurity Maturity Model Certification (CMMC) program, which would establish a comprehensive set of cybersecurity requirements applicable to...more

Bass, Berry & Sims PLC

Alaska Adopts New Out-of-State Pharmacy Requirements

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On January 19, the Alaska Board of Pharmacy (Board) announced statutory and regulatory changes that significantly impact “Out-of-State” (non-resident) Pharmacy registration requirements, impose additional licensure...more

Bradley Arant Boult Cummings LLP

Preparing a Cannabis Application: Five Things I Learned

Bob Seger’s “Against the Wind” is an anthem to love and growing old. Among its many great lines is “wish I didn’t know now what I didn’t know then.” Can you tell I recently turned 40? But I write today not about what I...more

BCLP

Through the Issuance of New Rules Aimed at Recidivist Brokers and the Firms That Hire Them, FINRA Loudly Exclaims to its...

BCLP on

Key Takeaways:  ..After years of warning firms of the need for enhanced diligence in retaining or hiring brokers with a significant history of misconduct, FINRA has adopted new rules to address such brokers. ..As set...more

Morgan Lewis

Japan to Establish Financial Market Entry Office and Promote English Filings

Morgan Lewis on

The Financial Services Agency of Japan (FSA) announced on November 6 that together with the local finance bureaus, it will establish a Financial Market Entry Office (FME Office upgraded from the current Financial Market Entry...more

Bricker Graydon LLP

Application deadline for BWC group-rating programs is fast approaching

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The Bureau of Workers’ Compensation (BWC) announced that private employers that are interested in the Deductible, Individual-Retrospective-Rating or One Claim programs must file an application by January 31, 2020, for the...more

Bricker Graydon LLP

Ohio Department of Health issues draft amendments to Certificate of Need rules

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The Ohio Department of Health (ODH) has prepared draft amendments to Ohio’s Certificate of Need (CON) rules. A number of these draft rule amendments address changes to the CON laws that were made in Ohio’s general operating...more

Ballard Spahr LLP

Colorado Issues Student Loan Servicer License Applications

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The Colorado Attorney General’s Office recently published licensing applications for entities that are engaged in servicing student loans owed by Colorado residents....more

Hogan Lovells

Complementary Medicines: the way forward

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According to a recent report published by Grand View Research, Inc., it is expected that by 2026, the global complementary and alternative medicine (CAM) industry will generate over USD 200 billion. The CAM industry, which...more

Best Best & Krieger LLP

SB 330 Limits Local Laws Over Housing Developments

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Part 4: New California Housing Laws - As part of Gov. Gavin Newsom’s pledge to create 3.5 million new housing units by 2025, he signed Senate Bill 330 on Oct. 9. The new law makes numerous changes to the Permit...more

Ballard Spahr LLP

HUD Publishes MTW Operations Notice and Request for First Round of New MTW Applicants

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HUD’s Moving to Work (MTW) Office has been busy! Earlier this month, HUD published for public comment a revised Operations Notice that will govern an expanded MTW program. ...more

Hogan Lovells

The FDA now offers cGMP Declarations

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The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

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