Staying Knowledgeable About FDA Changes

Are you developing a new parenteral formulation?  An orphan drug or a drug delivery system? Are you working on a clinical trial design?

If you’re involved with the development of new drugs, you’re probably keenly aware that the U.S. Food and Drug Administration (FDA) review process is vital for you, but you may not have the personnel to keep abreast of FDA news. The IRISYS Regulatory team keeps on top of changes in FDA regulations to ensure that our clients are up-to-date on issues that impact their products.

Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides insight into regulations under development or review throughout the federal government, including the FDA. This list of proposed regulations gives us a view into their policy agenda.

In a recent note, “Looking ahead: Some of FDA’s major policy goals for 2018,” Scott Gottlieb, M.D., Commissioner of the FDA, stated that the Agency is seeking to modernize and become more efficient. For example, they will be working to recognize “when scientific innovations warrant new, more flexible regulatory approaches in order to make sure advances in care can reach patients.”

Dr. Gottlieb also said the FDA “must continually adapt our regulations to enhance efficiency, improve our effectiveness, and update old and out-of-date requirements.” That was great news to our collective IRISYS ears!

Our expert FDA regulatory consultants, who provide strategic advice to companies in the U.S., and other countries including China, Japan, and Australia, were especially excited to hear what Dr. Gottlieb said about two FDA goals that are pertinent for our clients:

  • Harmonizing Global Standards:The FDA will be updating requirements for accepting foreign clinical data used to bring new medical devices to market. While helping to ensure the quality and integrity of clinical trial data and the protection of study participants, this rule should also reduce the burden on industry because it will harmonize with the standards currently used in drug regulation.

  • Removing Outdated Rules: We will propose to remove an outdated inspection provision for biologics and outdated drug sterilization requirements to remove barriers to the use of certain sterilization techniques.