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Third-Party › Food and Drug Administration (FDA)

McDermott Will & Emery

FDA Gives Companies a New Way to Fight Misinformation

McDermott Will & Emery on

Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

Knobbe Martens

FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs

Knobbe Martens on

Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties.  The Food and Drug Administration’s (FDA) Center for Devices and...more

Procopio, Cory, Hargreaves & Savitch LLP

Managing 3rd Party IP and Freedom to Operate in Drug Development

Procopio, Cory, Hargreaves & Savitch LLP on

When it comes to product development, the management of third-party intellectual property (IP) to ensure freedom to operate is of paramount importance. Drug development is no different. Imagine investing years of research,...more

Foley Hoag LLP

Next Up: Uniform Licensure Standards for Wholesalers and Third-Party Logistics Providers

Foley Hoag LLP on

Key Takeaways: ▪️ FDA has published a proposed rule proposing national licensing standards for prescription drug wholesale distributors and third-party logistics providers as well as standards for third-party accreditation...more

Arnall Golden Gregory LLP

FDA Issues Draft Guidance on 510(k) Third Party Review Program

Arnall Golden Gregory LLP on

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to...more

Mintz - Consumer Product Safety Viewpoints

Three More FSMA Rules Finalized As the Year Comes to a Close

Mintz - Consumer Product Safety Viewpoints on

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more

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