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Risk Management › Policies and Procedures › Food and Drug Administration (FDA)

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

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Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Gardner Law

From Paper to Practice: Compliance Policies that Work

Gardner Law on

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

Rivkin Radler LLP

Investigating Quality Incidents

Rivkin Radler LLP on

Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex...more

Brownstein Hyatt Farber Schreck

Can Employers Mandate COVID-19 Vaccines? Likely Not (Yet), Given Current FDA Emergency Use Authorization Status

Brownstein Hyatt Farber Schreck on

With distribution of COVID-19 vaccines moving ahead full-steam, an end to the pandemic may be in sight in the coming months. However, what is collectively known as the “new normal” still comes with a minefield of unanswered...more

ArentFox Schiff

FDA Issues Enforcement Policy for Ventilators and Other Respirators

ArentFox Schiff on

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

Hogan Lovells

COVID-19 Preparedness Considerations for the Food Industry

Hogan Lovells on

As you likely know, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are closely monitoring the spread of the novel coronavirus (COVID-19), a respiratory disease that has...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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