Executive Summary If sponsors will not work together to ensure that labeling for all drugs used as part of a combination regimen are in sync, then US FDA should take measures to streamline process and Congress may need to step in with carrot or stick incentives, a multi-stakeholder group suggests. Ensuring that drugs used together…
Executive Summary Stakeholder group’s proposed pilot program to correct outdated drug labeling calls for US FDA to identify older products needing updates and contract out for evidence reviews, but agency and generic drug industry raise concerns about complexity, resources and product liability. A streamlined pathway for adding important data to labeling of older drug products…
Executive Summary Former Commissioner Margaret Hamburg made advancing regulatory science a centerpiece of her tenure, but it sounds like the term ‘regulatory science’ has outlived its usefulness. The directors of the US FDA’s drug and biologic centers really don’t like the term “regulatory science.” Center for Drug Evaluation & Research Director Janet Woodcock…
Eligibility for clinical trials historically has been very conservative and included exclusion criteria that prevented or limited some patients with cancer from enrolling. However, on October 2, 2017, the American Society of Clinical Oncology, Friends of Cancer Research, and the Food and Drug Administration published clinical trial eligibility recommendations in a special issue of…
Executive Summary Sometimes data supporting drug’s initial approval can serve as confirmatory evidence for full approval of a subsequent indication based on an intermediate endpoint, US FDA Oncology Center of Excellence Director Pazdur says; proposed framework discussed at Friends of Cancer Research meeting would establish more systematic approach to streamlining supplemental approvals. Granting regular approval…
Executive Summary The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but it does not mean that HHS will do nothing about drug prices. On the contrary, it may make some high-profile action against pricing outliers all but inevitable. Alex Azar appears to be on…
FDA guidance documents always stress they don’t give anybody any rights and don’t bind the agency to anything they say—instead, they merely represent the agency’s “current thinking” on a topic. On the documents themselves, Janet Woodcock’s current thinking is that they’re too clunky. Woodcock, director of the FDA’s Center for Drug Evaluation and Research,…
It’s rare to hear a federal government person publicly put a time stamp on when things are coming out. Because who wants to speculate and then be wrong? On the record. To a reporter. Who will probably write about how you were wrong (and then tweet about it). So when Scott…
FDA is considering how real-world evidence (RWE) can be used to update product labels, and labeling may be the first area in which the agency develops a clear framework for the use of real-world evidence, agency Commissioner Scott Gottlieb told a group of stakeholders during Friends of Cancer Research’s (FOCR’s) annual meeting. “As we think…
Executive Summary The Trump Administration isn’t likely to drop the idea of having user fees pay the full cost of reviews. The pharmaceutical industry can afford higher fees, but industry officials worry about the perception if reviews are fully funded. “Bad idea.” That is how Amgen SVP-Global Regulatory Affairs & Safety Steven Galson characterized…
