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Policies and Procedures › Regulatory Requirements › Food and Drug Administration (FDA)

Gardner Law

From Paper to Practice: Compliance Policies that Work

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In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more

Eversheds Sutherland (US) LLP

Beyond the binary: How NIST is shaping the policies and practices of AI innovation and risk management

Eversheds Sutherland (US) LLP on

On September 24th and 25th, the National Institute of Standards and Technology (NIST) convened a symposium to generate new insights about the next steps needed to unleash AI innovations that will enable trust in this...more

Foley & Lardner LLP

2024 CPSC and FDA Enforcement Trends

Foley & Lardner LLP on

The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more

Foley Hoag LLP

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

Foley Hoag LLP on

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

Gardner Law on

When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Stinson LLP

Missouri Financial Institutions Must Prepare for Impending Marijuana Banking Challenges

Stinson LLP on

In November 2018, Missouri voters passed Amendment 2, setting in motion state regulated medical marijuana. Over the last month, the Missouri Department of Health & Senior Services (DHSS) began approving license applications...more

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