Executive Summary Adverse event reporting data will also be more readily available, Commissioner Scott Gottlieb says. The US FDA is looking to routinely publish clinical data used in regulatory decision making along with adverse event reporting data, in what appears to be just the latest effort of Commissioner Scott Gottlieb’s high profile effort to…
FDA Commissioner Scott Gottlieb said that Congress should legislatively lay out the government’s role in overseeing diagnostic tests, and that the broader diagnostic testing community should work together to understand how to commercialize tests so they better benefit patients. Gottlieb’s comments came during Friends of Cancer Research’s “A Blueprint for Breakthrough” event last Wednesday (Sept.…
FDA has a legitimate role to play in slowing down the cost of developing drugs, and it can do so by relying on good regulatory science, the agency’s commissioner Scott Gottlieb said. Speaking at a Washington event sponsored by Friends of Cancer Research and focused on precision medicine, Gottlieb said the agency’s Oncology Center…
Executive Summary ‘Believe it or not, we don’t have as many disease-specific guidances as you would suspect on the new drug side,’ Commissioner Gottlieb says. The US FDA is planning a guidance on Alzheimer’s drug development, part of a broader reform of the Office of New Drugs (OND). The guidance-writing initiative is intended to…
Executive Summary Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication; Patrick Kennedy is calling on CMS to provide reimbursement for opioid addiction treatment. US FDA Commissioner Scott Gottlieb said that “perhaps the biggest role” the agency can play in responding to the opioid crisis is…
FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS’ Convergence and a speech last week at…
Executive Summary New office will develop agency-wide patient engagement policy and serve as entry point for patient groups new to FDA, but will not interfere with existing relationships between advocates and the drugs and biologics centers, FDA Commissioner Gottlieb says. The US FDA’s proposed Office of Patient Affairs will develop and implement patient engagement best…
What exactly do you know about the prescription medication you’re taking? If you read the pill bottle itself, besides the drug name, you’ll see things like the medication strength and instructions for taking it properly. And the drug labeling information approved by the Food and Drug Administration, which regulates medications, extends beyond what’s on…
The approval of Novartis AG’s breakthrough therapy for a deadly form of leukemia opened the door to a new class of treatments even as its $475,000 price tag reignited the debate on how to value potentially life-saving drugs. Demonstrating its willingness to clear medicines faster, the U.S. Food and Drug Administration on Wednesday approved a…
