Medical Devices and Pharma
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QMSR Frequently Asked Questions
Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and...
EU MDR Compliance Consulting Services
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU...
Extensions for EU MDR and IVDR Implementation
Initial EU MDR and IVDR transition periods extended In 2023, the European Union granted an extension for the...
Implementation of the EU MDR and IVDR
A Significant EU Regulatory System Overhaul The implementation of the European Union's Medical Device Regulation (MDR) and...
FDA Grants Accelerated Approval to Tarlatamab-dlle
Treatment for lung cancer with progression following platinum-based chemotherapy On May 16, 2024, the Food and Drug...
FDA Approves New Imaging Drug Lumisight
A Significant Improvement for Surgical Oncology The U.S. Food and Drug Administration (FDA) has granted approval to...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
Medical Devices
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