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 is developing a policy by which the agency can approve subsequent indications of cancer drugs with less rigorous follow-up trials, FDA Commissioner Scott Gottlieb announced Thursday (Nov. 30).
For the second time, CMS agreed to cover a companion diagnostic on the day FDA approved it.
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.
FDA Commissioner Scott Gottlieb plans to pilot a new hiring process starting in 2018 after an internal report unveiled by Gottlieb Wednesday (Nov. 15) revealed FDA's hiring process needs to be fundamentally redesigned.
Generic stakeholders are clashing with FDA over what most thought were completed Generic Drug User Fee Amendments (GDUFA II) negotiations, namely the steps sponsors must take to be eligible for priority review.
FDA issued long-awaited guidance answering industry questions about how to comply with its menu labeling rule, slated to go into effect May 7, 2018, but the industry noted it will exercise enforcement discretion for out-of-compliance companies to help them comply with the law.
FDA's recent alert on alleged health risks associated with the herbal product kratom is being challenged by the American Kratom Association, which is petitioning the agency under the Information Quality Act to set up a special advisory committee of independent experts to review the accuracy and integrity of the data underlying FDA's advisory, and to hold a public meeting on the product.
FDA has introduced a new risk-based framework, accompanied by two final guidances and two new draft guidances, for regulating regenerative medicines, the agency announced Thursday (Nov. 16).
President Donald Trump announced Monday (Nov. 13) via tweet the nomination of Alex Azar to lead HHS, saying the former Lilly president "will be a star for better healthcare and lower drug prices!"
FDA Commissioner Scott Gottlieb on Wednesday (Nov. 8) called on brand drug makers to “end the shenanigans” of using loopholes to delay generics, while taking a step he said will help stem brand's use of Risk Evaluation and Mitigation Strategies to put off competition.
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