Medical Device and Pharmaceutical News
The latest information of interest to regulated industry. Bookmark this page to have a quick review for
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FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...
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...
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...
Important Recall Notice for BioMérieux VITEK 2 AST Kit
Class I Recall Notice BioMérieux Inc. has issued a crucial recall notice for its VITEK 2 AST kit, a vital tool in determining bacterial susceptibility to antibiotics. The Food and Drug Administration (FDA) classifies this recall as Class I, indicating a severe risk...
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...