Medical Devices and Pharma
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Prodigy Proclaim Spinal Cord Stimulation Systems
Significant advancement for chronic pain treatment On February 15, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of the Prodigy Proclaim and Proclaim XR Spinal Cord Stimulation (SCS) systems. This approval marks a significant step forward in...
Exposure to toxic materials during hemodialysis and dialysis
FDA announcement The US Food and Drug Administration (FDA) issued an announcement on March 7 to update its May 2022 letter to healthcare providers regarding the potential risks of exposure to toxic compounds when using hemodialysis and peritoneal dialysis. This update...
FDA Breakthrough Devices Program
Program assists needed products with access to US market The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate...
Approvals for FDA Breakthrough Devices
Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the marketing applications of the following products. What sets them apart? They are innovative devices that qualified and participated in FDA's Breakthough...
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Latest Posts
Rare Pediatric Disease Priority Review Voucher program
Expedite Development of New Pediatric Drugs The legislation for priority review of rare pediatric diseases is intended to expedite the development and approval of drugs for serious or life-threatening conditions affecting children. A summary of program and its key...
Key FDA Congressional Legislation
Several significant congressional legislative actions have directly affected the establishment, oversight authority, and processes of the US Food and Drug Administration (FDA). As a component of professional regulatory competencies, it is important for a regulatory...
Medical Devices and Pharmaceuticals
At Medical Devices and Pharma, we specialize in providing top-tier regulatory consulting services tailored to the medical device and pharmaceutical industries. Our deep understanding of policy, laws, regulations, and industry standardsand requirements will ensure your...
Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
Product Approval for Cervical Cancer Drug Exciting news emerged from the U.S. Food and Drug Administration (FDA) on April 29, 2024, as traditional approval was granted to tisotumab vedotin-tftv, marketed as Tivdak by Seagen Inc. (now a part of Pfizer Inc.). 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...
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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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