News & Analysis as of

Applications New Regulations

ArentFox Schiff

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

ArentFox Schiff on

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

Davis Wright Tremaine LLP

FCC Proposes New Regulations To Assess and Protect Against National Security Risks in Submarine Cable Networks

On November 21, 2024, the Federal Communications Commission ("FCC") approved a Notice of Proposed Rulemaking ("NPRM") focused on enhancing FCC review and oversight of the global subsea communications cable network through...more

Ankura

How Businesses Can Mitigate Legal Risks by Decommissioning End of Cycle Applications Forensically

Ankura on

Digital environment has brought flexibility and efficiency to business by having multi-cloud environments, and scalable cloud-hosted applications. However, it becomes a nightmare for Technical Operations (Tech Ops) to...more

Foley Hoag LLP - Cannabis and the Law

Commission Announces New Steps Forward to Advance Cannabis Research in the Commonwealth

The Cannabis Control Commission announced in an August bulletin that it will begin reviewing all Marijuana Research Facility license applications previously submitted to the Commission. A Research Facility license allows...more

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

LEGAL ALERT: Big Licensing Changes for Texas Insurance Professionals

On September 1, 2021, Texas HB 4030 went into effect, bringing with it several significant changes for Texas licensed (resident and non-resident) insurance professionals. As summarized below, HB 4030 implements several...more

BCLP

September 1st Implementation of FINRA Rule 1017(a)(7)

BCLP on

Recap of FINRA Rule 1017(a)(7) - If you recall from our May 11th alert, effective September 1, 2021, FINRA Rule 1017(a)(7) will require a member firm to file a CMA when a natural person seeks to become an owner, control...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

McDermott Will & Schulte

Brexit and COVID-19: Changes to the Regulation of Medicines

McDermott Will & Schulte on

The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines. On 16 October 2020, the UK Government made changes to...more

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