Regulatory Affairs Editorial

  1. Clinical News Roundup: CRS Files Lawsuit Against FDA

    Clinical News Roundup for the week of October 23, 2017 with information on CRS’ lawsuit against the FDA, FDA boosting patient access to medical devices, the Bracket acquisition of mProve, why Alzheimer’s drugs fail, and more.

  2. CRS Files Lawsuit Against FDA

    The watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, has filed a lawsuit against the FDA for denial of CRS’ citizen petition, which was originally submitted in June 2014 and has since had several amendments.

  3. FDA Draft Guidance On Electronic Records And Signatures: The Next Chapter

    The FDA has released a Draft Guidance titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. Certainly, the development of this draft guidance was driven by the repetitious questions the FDA has received from industry stakeholders as well as the extensive technology advancements.

  4. In Genome Editing Trials, The Effects Last A Lifetime

    Sangamo Therapeutics is involved in the quickly growing field of genome editing, but with a twist. The biotech is currently recruiting patients for three rare disease clinical trials which will mark the first time a company performs genome editing in vivo. In a nutshell, the treatments will replace a patient’s defective or missing gene with a therapeutic gene that will be permanently stitched into the liver cells of the patient. 

  5. Clinical News Roundup: China To Accept Foreign Clinical Trial Data

    Clinical News Roundup for the week of October 9, 2017 with information on China accepting foreign clinical trial data, Janssen launching iSTEP technology toolset for trials, FDA’s first Patient Engagement Advisory Committee Meeting, and CTTI issuing recommendations on investigator recruitment and retention.

  6. Can We Improve On

    Today, patients and pharma professionals looking for information on clinical trials generally visit On the site, users can search by condition/disease, country, and other keywords. Patients can find studies in which to participate, and researchers are able to find information on more than 250,000 studies being conducted in the U.S. and 200 other countries. But is it time for a new database that better meets the needs of pharma executives and researchers?

  7. Clinical News Roundup: FDA Says Clinical Trials System Is Broken

    Clinical News Roundup for the week of 9/24/2017 with information on FDA’s digital health pre-certification program, standard care in oncology, new clinical research definition causing concern for researchers, minorities in trials, and more.

  8. Mitsubishi Tanabe Tweaks Study Design For ALS Success

    A new treatment for adult patients with ALS, also known as Lou Gehrig’s disease, is now available to patients in the U.S. Produced by Mitsubishi Tanabe Pharma America, Inc. (MTPA),RADICAVA is the first ALS treatment to be approved by the FDA in more than 20 years. While it will not reverse the effects of ALS, a recent clinical trial found it slowed the decline in physical function of patients by 33 percent.

  9. Novartis: Pragmatic Clinical Trials & RWE Gain Traction

    In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.

  10. Pharma “Not Prepared” For New EU Data Protection Regulation

    Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.