The FDA's Center for Biologic Evaluation and Research (CBER) issued a standard operating policy and procedure on scheduling and conducting initial targeted engagement for regulatory advice on CBER products (INTERACT) meetings between staff and sponsors. The purpose of the meetings is to provide a preliminary, informal, nonbinding consultation at an early stage of development on issues regarding pharmacology/toxicology, clinical aspects of the development program, and chemistry, manufacturing and controls. INTERACT meetings can help sponsors conduct early product characterization and preclinical proof-of-concept studies; initiate discussion for new delivery devices; consider overall early phase clinical trial design elements; and identify critical issues or deficiencies to address in the development of innovative products.
A package of proposals to respond to the nationwide opioid crisis is on its way to becoming U.S. law. The Senate voted 98-1 to send the conferenced bill to the president. The White House has indicated that President Donald Trump will sign the bill, which is a consensus of separate House and Senate bills dealing with addiction prevention, treatment, research and enforcement. Included in the final bill are provisions granting the NIH more authority to accelerate research on nonaddictive pain relief and requiring drug and device companies to disclose payments made to nurse practitioners and physician assistants for promotional activities.
As part of its efforts to modernize clinical trials, the FDA released two draft guidances on master protocol and adaptive trial designs. The draft focuses on the use of master protocols for cancer drugs and includes a discussion of the information sponsors should submit to the agency and how they should interact to facilitate efficient review and mitigate risks. The second guidance addresses principles for designing, conducting and reporting the results from an adaptive clinical trial, which allows for planned modifications based on data collected while the trial is ongoing. "An adaptive design can provide a greater chance to detect the true effect of a product, often with a smaller sample size or in a shorter timeframe," the FDA said. It noted that patients may be more willing to enroll in an adaptive trial as it increases the probability that they will be assigned to the more effective treatment. Both guidances are open for a 60-day comment period.