Wednesday, June 7, 2017
Envigo has announced that its Research Models and Services (RMS) facility in Hyderabad, India, has been granted full accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council. In a letter to Envigo, AAALAC notified the company that it had met all the conditions required for full accreditation and commended the high quality facility and expertise of its people.
Spotlight Innovation, Inc. has announced that subsidiary Caretta Therapeutics, LLC, has begun the process of manufacturing Venodol topical roll-on, a non-addictive alternative to opioid and steroidal analgesics intended to provide relief from chronic pain. The manufacturing of Venodol is taking place at facilities located in Florida.
Some of the world’s largest funders of medical research and international non-governmental organizations agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.
Scott Gottlieb, M.D., new FDA Commissioner, has made his first remarks to FDA Staff in an FDA All Hands Meeting.
As legislative debate continues to contemplate the future of healthcare, prescription drug prices soared 8.77% in 2016, representing the fourth consecutive year of inflation above 8%. This represents an average annual price increase of 9.98% over the last three years.
Ireland has stepped up its bid to host the EMA with the official announcement being delivered and reiterated by Minister of Health, Simon Harris. The next step will now see Dublin scrutinized closely, particularly in regard to its regulatory capability. Ireland’s strength lies in the close relationship that the Health Products Regulatory Authority (HPRA) has established with the EMA and the wider network of medicines regulatory agencies throughout the EU. The HPRA has been an integral part of this regulatory system since the EMA was founded more than two decades ago.
This year, WHO will launch a pilot project for prequalifying biosimilar medicines, a step toward making some of the most expensive treatments for cancer more widely available in low- and middle-income countries.
Regulations for medical and diagnostic devices are changing in tune with advances in technology, new and innovative medical treatments, and the need for more effective diagnostic practices. Infiniti Research expects the market for medical devices to experience positive growth in the coming years as new rules and regulations eliminate counterfeit and dangerous products, increasing consumers’ trust and allowing established and reputable vendors to flourish.
TransCelerate BioPharma announced the availability of an enhanced technology-enabled Common Protocol Template (CPT). This update to the CPT is in alignment with the common protocol template launched by the FDA and the NIH. This collaborative effort reinforces the need for harmonized protocol formats and content that aligns objectives and endpoints with accepted data standards.