News & Analysis as of

Manufacturers Risk Management Regulatory Requirements

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Accelerynt, Inc.

Fortifying Your Manufacturing Business: The Imperative of Cybersecurity Services and Training

Accelerynt, Inc. on

Lately, I have been asked a lot about security in Business Central and how good it is… Permissions, Roles, Field Level Permission with an APP, and so on. How do you know if anything has been compromised, or if you have a...more

Mintz - Health Care Viewpoints

Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more

Hogan Lovells

Business integrity for consumer companies

Hogan Lovells on

Consumer companies around the world are incorporating sustainability, business integrity, and brand purpose into their business operations. This can include procuring ethically sourced products, ensuring fair pay, or...more

Mintz

FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance

Mintz on

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more

Robinson+Cole Manufacturing Law Blog

TRAINING DEADLINE EXTENDED: Time to Catch the “Train” – The New York Gender-Based Harassment Train

Last month, I posted about New York State’s recently enacted law mandating all New York State employers adopt Sexual Harassment Policies and train all employees annually. ...more

Hogan Lovells

Legislative and Regulatory Update on Federal Supply Chain Risk Management

Hogan Lovells on

The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. ...more

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