Science and Enterprise

Tag: FDA

  • FDA to Tap Outside Specialized Experts on Devices

    The Food and Drug Administration announced plans to form a new network of outside experts to offer specialized advice on medical devices. The FDA is also seeking public comment on draft procedures for recruiting and operating this network. FDA’s Center for Devices and Radiological Health (CDRH), the part of the agency that regulates medical devices,…

  • FDA Approves Opioid Analgesic for Chronic Pain

    Janssen Pharmaceuticals in Raritan, New Jersey says the Food and Drug Administration has approved its drug Nucynta ER for the management of moderate to severe chronic pain in adults. The company is a division of drug manufacturer Johnson & Johnson. Nucynta ER is an oral analgesic taken twice daily, and prescribed when a continuous, around-the-clock…

  • Chili Pepper Ingredient Can Help Ease Sinus Problems

    A study led by a University of Cincinnati allergy researcher has found that a nasal spray containing an ingredient derived from hot chili peppers (Capsicum annum) may help relieve certain types of sinus inflammation. The findings by Jonathan Bernstein of the UC medical school and colleagues appear in the August issue of the journal Annals…

  • FDA Gives Accelerated Approval to Lymphoma Drug

    The U.S. Food and Drug Administration approved the drug Adcetris (brentuximab vedotin) developed by Seattle Genetics of Bothell, Washington, to treat two types of lymphoma. FDA approved Adcetris under an accelerated review procedure for promising drugs to treat serious diseases. Lymphoma is a type of cancer that affects the cells that play a role in…

  • NIH Approves Four More Embryonic Stem Cell Lines

    BioTime Inc. in Alameda, California says it has received approval from National Institutes of Health (NIH) for adding four human embryonic stem (hES) cell lines to the Human Embryonic Stem Cell Registry. Two of the company’s hES cell lines are already listed in that registry. All of the lines were developed by Biotime’s subsidiary ES…

  • FDA Issues Regulatory Science Modernization Plan

    The U.S. Food and Drug Administration today released its Strategic Plan for Regulatory Science that calls for modernization of the science used to protect the nation’s food and drug supplies. The plan describes the agency’s intent to improve the ways it develops and evaluates new products and materials, as well as improve the way it…

  • FDA Issues Draft Clinical Trial, Benefit-Risk Guidelines

    The U.S. Food and Drug Administration has issued separate draft guidelines involving medical devices, one for designing better clinical trials, and the other for benefit-risk determinations. Both documents are open for public comment for 90 days. FDA’s guidance documents generally do not establish legal responsibilities, but instead describe FDA’s current thinking and recommendations. The clinical…

  • FDA Approves First Treatment for Scorpion Stings

    The Food and Drug Administration approved Anascorp, the first specific treatment for a sting by Centruroides scorpions, commonly known as the Arizona Bark Scorpion in the United States. The drug was developed by Rare Disease Therapeutics Inc. in Franklin, Tennessee, licensing research by University of Arizona in Tucson and and two research institutes in Mexico.…

  • FDA Alerting Pharmas Over Work of Contract Research Company [UPDATED]

    The Food and Drug Administration has notified pharmaceutical companies that hired contract research organization Cetero Research of Houston, Texas that the work done by Cetero may need to be redone or confirmed. The alert to pharmaceutical companies follows an FDA letter sent yesterday to Cetero identifying problems in the company’s research, including falsification of entries…

  • FDA Outlines Regulatory Science Needs for Drug Evaluations

    The Food and Drug Administration published its proposed needs for regulatory science in the agency’s Center for Drug Evaluation and Research (CDER), its main drug regulating division. The document is available for public review and comments, which close 60 days following the 21 July 2011 publication. CDER regulates over-the-counter and prescription drugs, including biological therapeutics…