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Regulatory Requirements › Risk Management › Filing Requirements

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Ballard Spahr LLP

NYDFS Requires Filing of Preparedness Plans and Financial Risk Assessments Related to COVID-19

Ballard Spahr LLP on

In an Industry Letter, the New York State Department of Financial Services (NYDFS) is requesting assurance that New York State regulated institutions have preparedness plans in place to address operational risk, and it is...more

Kramer Levin Naftalis & Frankel LLP

SEC Provides Conditional Regulatory Relief and Assistance for Companies Affected by the Coronavirus Disease 2019 (COVID-19)

Kramer Levin Naftalis & Frankel LLP on

On March 4, 2020, the Securities and Exchange Commission (the Commission) announced that it is providing conditional regulatory relief for certain publicly traded company filing obligations under the federal securities law in...more

Ballard Spahr LLP

Practical Tips for Ensuring Your AML Program Withstands the Scrutiny of Regulators

Ballard Spahr LLP on

First Post in a Two-Part Series - How do financial institutions get in trouble with their regulators? Recent AML enforcement actions suggest that the following two failures are at the heart of most of these actions: (1)...more

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