Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
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.
FDA proposed to delay by an additional two to four years the compliance dates for non-sprout produce to meet the food safety law's agricultural water requirements, stating in a proposed rule out Tuesday (Sept. 12) that the delay will give the agency time to simplify the requirements to make them less burdensome and less costly for farmers.
The American Academy of Pediatrics applauded FDA's planned effort to cut back abuse of an exemption in the Orphan Drug Act that allows drug developers to avoid the requirement to study drugs for pediatric use.
FDA Commissioner Scott Gottlieb said the agency will soon make more health-related data public, including data sets compiled by FDA, adverse event reports, and letters on Risk Evaluation and Mitigation Strategies (REMS).
FDA Commissioner Scott Gottlieb said the agency is taking steps to make the clinical trial process smoother and less costly for sponsors, including: embracing seamless trial designs, which abandon the traditional three phases of trials; using master protocols; and relying on advanced computational modeling.
FDA Commissioner Scott Gottlieb told stakeholder Monday (Sept. 11) he wants to see the agency more systematically review existing regulations.
FDA Commissioner Scott Gottlieb hopes to bring the agency’s policies on commercial speech in line with recent industry-friendly legal precedents, the agency head signaled during a Monday (Sept. 11) speech at the 2017 RAPS Regulatory Convergence.
President Donald Trump's regulatory czar directed agencies on Thursday (Sept. 7) to cap their regulatory costs for fiscal 2018, and indicated the Office of Management and Budget expects each agency to propose a net reduction in regulatory costs.
Stakeholders on both sides of the off-label debate have seen little indication as to where Scott Gottlieb will take the agency on the contentious issue, but neither side appears overly troubled by the lack of action on the issue in his first 100 days, and some call it a smart approach.
FDA plans to unveil a new Strategic Policy Roadmap outlining the agency's policy priorities, one of which will be rolling out new pre-clinical science policies aimed at streamlining the investigational new drug and biologics license application filing processes, Commissioner Scott Gottlieb told a diverse group of patient advocates, members of the drug and device industry, medical experts and other stakeholders during Research!America’s 2017 National Health Research Forum on Thursday (Sept. 7).
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