Regulatory Affairs Editorial

  1. Clinical News Roundup: RBM Leads To Cost Savings

    Clinical news roundup for the week of April 1, 2017 with information on RBM and cost savings, a culture change around clinical data, proposed clinical research tax credits, increasing patient diversity, the pharma industry in Mexico, and patient trust and satisfaction.

  2. Lessons Learned From The Rise And Fall Of Scios

    When Roger Mills began his career in the medical profession, he never imagined he would one day end up working for a Big Pharma company or find himself in the middle of a controversy over attempts to bring a new cardiology drug to market. That journey would see a small company teeter on the brink of bankruptcy, experience the highs of a new drug approval and acquisition by a large company, and finally, the downfall and collapse of the approved medicine.

  3. Clinical News Roundup: Biopharm Seeks More FDA Input On Endpoints

    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.

  4. How Will Changes At FDA Impact Clinical Trials?

    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.

  5. Are You Conducting Proper CRO Oversight?

    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.

  6. FDA Reports On 2016 Diversity Results

    In a recent blog post, John Whyte, director of professional affairs and stakeholder engagement at CDER, notes until the late 1980s, clinical trials were conducted primarily on men. But a lot has changed over the last 30 years. We now know that some drugs affect men and women differently. This is why it is important for sponsors to test drugs on the appropriate patient populations, especially when developing “novel drugs.”

  7. Clinical News Roundup: CTTI Issues Recommendations For Pediatric Trials

    Clinical news roundup for the week of February 12, 2017 featuring information on new CTTI recommendations, China’s trial application backlog, adaptive trial design adoption, growth in the mHealth market, and Merck’s Patient-Centered Cancer Care Access.

  8. Paratek Successfully Tackles Patient Challenges in Phase 3 Trial

    Paratek bills itself as a pharmaceutical company developing innovative medicines based on tetracycline chemistry. In this Q&A, Dr. Evan Loh, president and COO for Paratek, discusses some of the clinical challenges faced when enrolling patients for the ongoing Phase 3 studies. In addition, he notes how completing these studies will position the company for a new drug application as early as the first half of 2018.

  9. Thailand Puts Increased Focus On Clinical Trials

    For countries hoping to see greater gains in healthcare innovation and economic prosperity, growing the clinical research industry is one way to achieve both goals. Thailand now seems to be an emerging country for trials, as it is a primary gateway into Asia and a central player in the region.

  10. Clinical News Roundup: Should Patient Advocacy/Private Funds Connection Raise Concerns?

    Clinical news roundup for the week of January 15, 2017 with information on the financial relationship between pharma and patient advocacy groups, the FDA take on diversity in trials, HHS rules on patient safety, venture funding of mobile apps, and more.