FDA Proposes New Measures to Minimize Non-Human Primate Testing for Monoclonal Antibody Development
The U.S. Food and Drug Administration (FDA) has released proposed guidance aimed at reducing or eliminating the use of six-month…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Latest News
FDA’s Coordinated Crackdown: $1 Million Worth of 7-OH Opioids Seized in Missouri
The U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Justice (DOJ), took decisive action on…
Europe
Swissmedic Opens Recruitment for Experienced Software Architect in Regulatory IT
Swissmedic, Switzerland’s key authority for the oversight of therapeutic products, has recently issued a call for an experienced Software Architect…
Europe
Swissmedic Opens Role for Cloud Engineering Expertise in Medical Device Regulation
Swissmedic, Switzerland’s authority for medical devices and therapeutic products, announces an exciting cloud engineering position. Key stakeholders in clinical, quality,…
Latest News
FDA Rolls Out Advanced AI Tools for Enhanced Regulatory Operations
The U.S. Food and Drug Administration (FDA) has announced a significant milestone: the organization is deploying agentic artificial intelligence (AI)…
Latest News
FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed by Glycar SA. Health…
Europe
Swissmedic Updates Guidance: Packaging Leaflets for Healthcare-Only Medicines Optional
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its packaging guidance for human…
Europe
Temporary Approval Announced for Sales of Opdivo 240 mg Infusion Solution in Italian Packaging
Swissmedic has issued a temporary approval enabling the distribution of Opdivo 240 mg/24 ml concentrate for infusion solution in Italian-language…
Europe
Swissmedic Grants Temporary Approval for Nemluvio Injection Pen Packaging in German
Swissmedic has announced the temporary authorization of Nemluvio—or Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung im Fertigpen—for distribution within…
Europe
International Council for Harmonisation Convenes: Regulatory Updates for Pharmaceuticals Highlighted
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) convened its Assembly meeting in Singapore…
Europe
Medicine Safety Alert: Baclofen 10mg Tablets Missing Correct Patient Safety Information
A safety advisory has been issued for Baclofen 10mg tablets, manufactured by Special Concept Development UK Limited. Regulatory authorities have…
Europe
Regulatory Update: MHRA Highlights November 2025’s Key Safety Insights for Medicines and Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its latest safety roundup for November 2025, aimed at providing…
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