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FDA Remote Regulatory Assessments Are Not So Remote Anymore

The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more

FDA on Board With Continuing Remote Inspections

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more

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