FDA’s Center for Drug Evaluation and Research (CDER) is launching a new center that will focus on promoting innovative clinical trial approaches through internal and external collaboration, to be known as the Center for Clinical Trial Innovation (C3TI). The center will kick off with projects on point-of-care or pragmatic trials, Bayesian analyses, and trials using selective safety data collection. The center was announced in a Federal Register notice Monday (April 15). “CDER’s long-standing efforts to embed innovation in clinical...

Democratic leaders of the House Education & the Workforce Committee are urging the Department of Labor to take a close look at the ERISA Advisory Council’s recommendations on ending disability benefits’ discriminatory treatment of conditions related to mental health/substance abuse and let lawmakers know whether additional authorities or resources are needed to implement the proposals. Most long-term disability plans, which are accessible to about 35% of private workers, currently treat disabilities arising from behavioral health conditions differently than those that...

CMS is telling pharmacies and other stakeholders to start preparing now for an upcoming national coverage determination (NCD) under Part B for preexposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV, laying out coding and other implementation details the agency says pharmacies need to have in place so they won’t disrupt patient access when the NCD comes out. If finalized, the drugs will be immediately covered under Part B instead of Part D. If finalized, CMS says the NCD would...

FDA is planning to hold a public meeting on financial transparency and efficiency of the prescription drug, generic drug and biosimilar user fee programs in June, and is soliciting public comments ahead of the event on topics addressed in the programs’ commitment letters. The notice was posted in the Federal Register Tuesday (April 9). The meeting will be held virtually on June 6. “This meeting will provide FDA with the opportunity to update interested public stakeholders on topics related...