RAPS

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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FDA's Record Year: A Look at 2018 New Drug Approvals

The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency@s Center for Drug Evaluation and Research (CDER ...
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FDA finalizes bacterial pneumonia drug development guidances

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7-year FDA review finds improved GCP compliance

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
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9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape

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Thousands of FDA staff fired in latest RIF

Thousands of workers at the US Food and Drug Administration (FDA) were abruptly fired on 1 April as part of President Donald Trump@s effort to reduce the size of the federal government. Many agency ...
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The Critical Role of Thickeners in the Therapeutic Medical Management of People with Dysphagia

The regulatory environment of FSMPs in the EU has been previously well-described by Bushell. 61 The authors show the definition of FSMPS is broad enough to encompass a wide variety of FSMPs necessary ...
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Life after the FDA: Career paths for former regulators

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources ...
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Study: Data lacking for AI-enabled medical devices cleared by FDA

Clinical performance data for medical devices with artificial intelligence (AI) features is often unavailable, making it difficult to assess real-world outcomes and potentially jeopardizing safety, ...
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DOGE claims $30M savings from canceling 30 FDA leases

The Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...
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FDA panel debates label change on SSRI use during pregnancy

A US Food and Drug Administration (FDA) panel convened on Monday to explore the impact of selective serotonin reuptake inhibitors (SSRIs) on fetal development, with some panel members proposing that ...
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The impact of US state law initiatives for food ingredients on the food industry

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...