Clinical News Roundup for the week of March 19, 2017 with information on FDA, NIH, clinical trial applications, pharma’s reputation, and an algorithm to make trials safer and less costly.
The 21st Century Cures Act has been approved by both the House and Senate, and late last year was signed into law by President Obama. The 996-page bill includes changes to the way FDA regulates drugs, medical devices, and biologics. In 2017, we have seen a change in administrations and will likely see a change in leadership at the FDA. I took this opportunity to touch base with David Rosen, co-chair of the life science practice at Foley & Lardner LLP and a law practice consultant. In this Q&A, Rosen shares his thoughts on the new legislation, changes coming to FDA, and why the patient perspective needs to remain a primary concern of the drug development industry.
Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations.
In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).