Regulatory Affairs Editorial

  1. Fear, Indecision, And The Memo To File

    How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself?

  2. Doctors And Researchers Attempt To Stop Right-To-Try Legislation

    A group of academics who work at the intersection of drug development and medical ethics are jumping into the kerfuffle over proposed Right To Try (RTT) legislation, noting they are deeply concerned about the ramifications of a federal RTT law for patients and families. In a letter to the leadership of the House of Representatives’ Energy and Commerce Committee health subcommittee, the group notes it has “strong opposition’ to the pending legislation.

  3. Designing Clinical Studies To Avoid Regulatory Scrutiny

    Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.

  4. As Turns 10, Will We See Compliance Improve?

    The FDAAA Title VIII, which required clinical trial results to be disclosed on, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.

  5. Clinical Trial Deaths — Will Clearer Informed Consent Documents Be Enough?

    In October 2017, the watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, grabbed headlines when it filed a lawsuit against the FDA. The suit takes aim at informed consent regulations, seeking to ensure that potential trial participants receive sufficient information to truly evaluate the risks and benefits of participating in a drug trial.

  6. Best Practices In FDA Orphan Drug Submissions

    A common misconception in the industry is that an orphan designation is one of the easier regulatory milestones to reach. The guidance the FDA has issued on obtaining an orphan designation is relatively straightforward, perhaps so much so that it is easy to overlook some of its key elements.

  7. CRS Lawsuit: Does FDA Guidance Require More Clarity?

    The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.

  8. 3 Steps To Capitalize On Real-World Data Under 21st Century Cures

    Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.

  9. Trial Aims To Kill Cancer Without Chemotherapy Side Effects

    Getting a new oncology drug to patients involves navigating an obstacle course of costs, timelines, safety and effectiveness data, and regulations. Starting the clinical process with a molecule that has already been proven to kill cancer cells and be safe for patients will eliminate much of the risk. That is exactly what NanOlogy, a clinical-stage oncology company, is attempting to do.

  10. Clinical News Roundup: FDA Awards Funding To Pediatric Clinical Trials

    Clinical news roundup for the week of November 6th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.