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.
Some biologics experts are perplexed by the Trump administration’s argument that subjecting biologics products to United States Pharmacopeia (USP) monographs would hamper innovation.
Americans for Safe Access and data company Aurelius Data Inc. have partnered to develop a research platform that will compile use, perception and biometric data on consumers who are using cannabis products to help their medical conditions, and will make those insights available in a subscription-based database that allows users to see what regimens patients are using.
Former FDA Commissioner Scott Gottlieb named payer tactics as one of the biggest obstacles facing the gene therapy space, as novel drugs seeking coverage after receiving FDA approval are often viewed by payers as not having enough data on which to base a coverage decision.
FDA made a sizeable notch in its enforcement belt on Friday (June 14), announcing that it requested U.S. Marshals seize $3.5 million worth of dietary supplements.
After a patient died and another developed an invasive infection from fecal microbiota transplantation (FMT) treatment, which is not approved by FDA, the agency issued a safety alert urging health care providers to communicate the risks of the treatment to their patients, and to test stool donors and stool samples for multi-drug resistant organisms (MDROs) before use.
Former FDA Commissioner Scott Gottlieb defended drug maker Pfizer’s choice to not investigate signals that its anti-inflammatory drug Enbrel appeared to reduce the risk of Alzheimer’s, as the Washington Post reported on June 4.
FDA asks a Maryland court to give makers of all e-cigarettes and electronic nicotine delivery system (ENDS) products at least 10 months to submit premarket applications.
As part of their investigation into the dangers of illicit fentanyl, much of which comes from China, a bipartisan group of House Energy & Commerce Committee leaders wrote to FDA Acting Commissioner Ned Sharpless and heads of five other federal agencies to request briefings on the effect the opioid epidemic is having on public health and on their solutions for stopping the flow of illicit fentanyl into the United States.
Sen. Tim Kaine (D-VA) defended his and Senate Majority Leader Mitch McConnell’s (KY) tobacco-to-21 bill against criticism from health advocacy groups and some senators that the bill would put states at risk of losing funding for substance abuse treatment programs and would allow the tobacco industry to undermine anti-tobacco proposals at the state level.
FDA finalized guidance on Tuesday (June 11) that details the type of information sponsors of electronic nicotine delivery systems should include in their premarket approval applications.
© 2002-2024. Inside Washington Publishers | Contact Us