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Developments in US trade policy affecting the dietary supplement industry

This article provides a comprehensive overview of recent changes in US trade policy. It highlights key developments such as new global tariffs and bilateral trade agreements, sector- and ...
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Medtech industry calls for major reforms to MDR and IVDR

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...
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Convergence 2025: Adapting to change and uncertainty in the regulatory landscape

Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific ...
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FDA lists its upcoming research priorities for generic drugs

The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency@s ...
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Stakeholders: FDA combo products UDI guidance is inconsistent with regulation

Several stakeholders have raised concerns that parts of the US Food and Drug Administration@s (FDA) draft guidance on unique device identifier (UDI) requirements for combination products are ...
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FDA official: Clinical, CMC teams should be on the same page when developing CGTs

WASHINGTON @ Denise Gavin, the director of the Office of Gene Therapy at the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), emphasized that clinical ...
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FDA posts more than 100 warning and untitled letters in ad crackdown

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...
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FDA finalizes guidance on alternative inspection tools

The US Food and Drug Administration (FDA) on Thursday finalized its guidance on the use of alternative tools for conducting preapproval inspections (PAI) or prelicense inspections (PLIs) in lieu of ...
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Industry suggests changes to FDA’s CMC readiness pilot

Officials from the US Food and Drug Administration (FDA) and representatives from the pharmaceutical industry shared insights on the agency@s Chemistry, Manufacturing, and Controls (CMC) Development ...
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Biosimilars: FDA finalizes supplement classification guidance

The US Food and Drug Administration (FDA) on Monday published final guidance to assist sponsors in identifying the appropriate supplement category for biosimilar prior approval supplements @ both ...
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Kennedy clashes with lawmakers over vaccine policies, CDC firing

Health and Human Services Secretary Robert Kennedy Jr. clashed with Democratic senators during a Senate hearing over his vaccine policies and the recent firing of the director of the Centers for ...
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Groups pressure CMS to speed coverage of breakthrough devices after FDA authorization

AdvaMed and dozens of other stakeholders have written to the Centers for Medicare and Medicaid Services (CMS) to reconsider implementing a reimbursement process for breakthrough devices and ...