The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and ...
The US Food and Drug Administration's (FDA) Office of Combination Products (OCP) has released a new final regulation on the current good manufacturing practices (cGMPs) used in the manufacture of ...
The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device ...
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