Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
FDA Warns of Risks with OTC Pain Relief Products
The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion,...
Urgent Recall Alert for Methocarbamol Injection by Eugia US LLC
Attention Consumers, Healthcare Providers, and Distributors: Eugia US LLC, formerly known as AuroMedics Pharma LLC, announced a voluntary recall on March 28, 2024 of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) 10mL Single Dose Vial....
QMSR Design and Development – Design Inputs and Outputs
ISO 13485:2016 Design and Development Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and development planningClause 7.3.3 - Design and development inputsClause 7.3.4 - Design and development outputsClause 7.3.5 - Design and development...
QMSR Design and Development Controls
From Design Control to Design and Development Both the QSR and QMSR have the same design and development phases of planning, inputs, outputs, verification, validation, transfer, and design changes. All of the 21 CFR 820.30 Design Control requirements are covered in...
ISO 9000 Clause 3 Definitions
Establishing a Common Language for Quality Management Systems ISO 9000:2015, Quality management systems — Fundamentals and vocabulary, serves as the cornerstone of the ISO 9000 family of standards, providing essential terminology and principles for quality management...
Request QMSR Information
QMSR Information Request Form Are you ready for the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR)? The new QMSR framework aligns more closely with ISO 13485, bringing significant changes to how medical...
ICH: The International Council for Harmonization
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a pivotal role in shaping global pharmaceutical practices, ensuring the quality, safety, and efficacy of medicines worldwide.The International Council...
Regulatory Information Management Systems (RIMS)
What Is a RIMS System? A Regulatory Information Management (RIM) system is a software solution designed to streamline and automate the management of regulatory information and processes within the life sciences industry, including pharmaceuticals, biotechnology, and...
FDA Approves Versatile Antibiotic Zevtera for Three Key Infections
FDA Approves Versatile Antibiotic Zevtera for Three Key Infections The U.S. Food and Drug Administration (FDA) announced today that the fight against bacterial infections has gained a significant boost with the recent approval of Zevtera (ceftobiprole medocaril sodium...
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
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FDA Approves Xolremdi for WHIM Syndrome
A Breakthrough for Rare Infections In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has granted approval for Xolremdi (mavorixafor) capsules, marking a significant milestone in the treatment of WHIM syndrome. Let's delve into what this...
FDA Approves Anktiva for Bladder Cancer
New Drug Approval In a significant development for patients battling BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the Food and Drug Administration (FDA) has granted approval to nogapendekin alfa inbakicept-pmln, marketed as Anktiva by Altor...
Health Alert Regarding Rare Pregnancy Complication
FDA Safety Communication In a recent health safety alert, the U.S. Food and Drug Administration (FDA) has cautioned healthcare professionals about the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines, including...
Risks with Exactech Equinoxe Shoulder System
FDA Safety Communication April 19 Update: Exactech has initiated a recall to remove Equinoxe Shoulder System devices packaged in the defective bags from facilities’ unused inventory. To see if your device is affected by the recall, visit Exactech’s Recall...
Quest Cat Food Recall Expanded Due to Low Thiamine Levels
Quest Cat Food Recall Expanded Due to Low Thiamine Levels On February 26, 2026, Go Raw LLC expanded its voluntary recall of...
FDA Warning Letter Cites Key CGMP and Data Integrity Failures
FDA Warning Letter Highlights Fundamental CGMP and Data Integrity Failures The FDA has issued a Warning Letter to A. Nelson...
Implications of the New Federal Vaccine Schedule for Children
The New Federal Vaccine Schedule for Children: What Changed and What Are the Implications?Authors: Jennifer Kates and Josh...
When Generic Drugs Are Not Equivalent
Fighting for BreathLung transplant patient Hannah Goetz’s life depended on the generic version of a critical drug. It was...
Labeling Correction for TRUE METRIX® Blood Glucose Meters
Labeling Correction for TRUE METRIX® Blood Glucose Meters Highlights the Critical Role of Clear Error Messaging Trividia...
Proposed Bill Would Increase Drug Labeling Transparency
Proposed Legislation would Require Generic Drug Labels to Bear Manufacturer, Location, and Key Suppliers ProPublica's RX...
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.
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