Regulatory Affairs Editorial

  1. Senate Revises Right-To-Try, CUPA Still Gives Thumbs Down

    In August, the Senate passed, via unanimous consent, a bill that claims to improve access to experimental drugs for patients. While the Senate made numerous changes to the original Right-To-Try (RTT) bill, the New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access (CUPA), which came out against the bill advanced by the House, remains steadfast in its opposition to the legislation.

  2. Clinical News Roundup: FDA Says Three-Parent Baby Technique is Illegal

    Clinical News Roundup for the week of August 6, 2017 with information on mitochondrial replacement technology, PRA acquiring Symphony Health, and startup monARC building patient networks for next-generation clinical trials.

  3. DIA Trends: Technology, Trial Design, & Regulators

    In his role as SVP and managing director, Americas for DIA Global, Sudip Parikh has the opportunity to look across the pharmaceutical industry at what companies are doing in regard to clinical trials. In this article, he shares his insights into what the industry can do to make trials more efficient and speed up the entire trial process.

  4. Clinical News Roundup: LabCorp To Acquire Chiltern

    Clinical News Roundup for the week of July 30, 2017 with information on LabCorp acquisition of Chiltern, merger of INC Research and inVentiv Health, FDA Reauthorization Act, Right-To-Try legislation, and more.

  5. Should We Rethink Randomized Clinical Trials?

    If we want to accelerate the drug development process, is it time to reconsider randomized clinical trials? That was the main question asked at a recent colloquium that included industry leaders from pharma networks, academia, patient groups, major medical centers, and the FDA.

  6. Clinical News Roundup: FDA Sets Inaugural Meeting Of Patient Engagement Advisory Committee

    Clinical News Roundup for the week of July 23, 2017 with information on FDA’s Patient Engagement Advisory Committee, FDA guidance of IRB waivers, FDAnews joining WIRB-Copernicus Group, Right-To-Try legislation, Type 1 diabetes vaccine headed for trials, and more.

  7. Cell Therapy Trial Targets Type 1 Diabetes In Children

    Getting adult patients to take part in a clinical trial is difficult. When developing a treatment for a childhood disease, that recruitment challenge becomes even more difficult. The combination of patient age and the experimental nature of a treatment can cause concern amongst both parents and the FDA. Caladrius Biosciences is a company dealing with that challenge. The company is developing a cell therapy technology based on a patient’s own T-cells.

  8. FDA Issues Draft Guidance On Electronic Records

    The FDA has issued draft guidance for industry titled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.” The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials.

  9. Clinical News Roundup: Scientists Hate NIH Definition of Clinical Trials

    Clinical News Roundup for the week of July 16, 2017 with information on NIH’s new definition of clinical trials, Hispanics in trials, misleading registrations on, clinical trials in South Korea, and more.

  10. Could RTT Ease Access To Critical Drugs?

    The NYUSOM Working Group on Compassionate Use and Pre-Approval Access recently released a paper noting inherent problems with the proposed Right To Try (RTT) legislation proposed by Sen Ron Johnson and 46 cosponsors. The key findings were that RTT legislation would not allow patients to get drugs faster, and that FDA actually helps, rather than harms patients. Of course, not everyone agrees with the findings of the Working Group. One of those individuals is Michael S. Smith, Vice President of the Gastroparesis Patient Association for Cures and Treatments, Inc. and a patient who has lived with Chronic Intestinal Pseudo-Obstruction for nearly 30 years.