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Food and Drug Administration (FDA) New Guidance Recordkeeping Requirements

Hogan Lovells

FDA Issues Proposed Rule Extending Compliance Date for Food Traceability Rule

Hogan Lovells on

The United States Food and Drug Administration (“FDA”) recently issued a proposed rule to extend the compliance date for the final rule “Requirements for Additional Traceability Records for Certain Foods” (the “Traceability...more

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Regulators Must Write Cloud-Specific Guidance

Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Robinson+Cole Health Law Diagnosis

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more

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