Regulatory Affairs

  • Regulatory Affairs
  • Drug scheduling in the U.S.A.  under the 1970 Controlled Substance Act places drugs into unscheduled or scheduled status.

    Many of my colleagues and I are members of the Cross-Company Abuse Liability Council (CCALC), where I have been a co-chair for the past seven years, and a member for 15.

    The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

    There’s a lot of life science content out there, so for your convenience, we’ve curated a selection of expert insights, tips, case studies, and scientific and regulatory information. Catch up on what you might have missed below!

    Regulatory Comparisons for Starting First-In-Human Clinical Trials

    Where you decide to conduct your early-phase clinical trials could have a significant impact on your costs and timelines. There are lots of factors to consider when making that decision—in some cases, performing clinical trials in Canada and the U.S. simultaneously can be the right step towards optimizing your program. But as sure as maple syrup is great on pancakes, and mustard is better on hot dogs, some things are simply just a better fit.

    There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!

    Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines

    We want novel therapies to be approved fast, while being safe for us. Regulatory agencies around the world strive to balance the critical elements of speed and safety; at the same time, a rigorous review process is a must. 

    Canadian research facilities are becoming a popular choice for American and European sponsors, carrying out hundreds of clinical trials each year.

    Timely completion of necessary studies is a critical element of drug development, bringing important treatments to patients in a safe and cost-efficient way.

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