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FDA hopes to encourage more diversity in clinical trials through draft guidance that lays out how drug and biologic sponsors can broaden eligibility criteria, avoid unnecessary exclusions and reduce burdens on trial participants.
Senate Minority Leader Chuck Schumer (D-NY) wants FDA to expedite the review of the 12 sunscreen ingredients that the agency recently determined, via a proposed rule in February, did not have sufficient evidence to be deemed safe and effective.
Opioid maker Insys Therapeutics, which manufacturers fentanyl product Subsys, will plead guilty to five counts of mail fraud, pay millions in fines and pay to settle allegations that it violated the False Claims Act, the Department of Justice (DOJ) announced Wednesday (June 5).
FDA for the first time has granted marketing authorization to a device intended to help relieve pain in adolescents with irritable bowel syndrome (IBS) through the use of electrical nerve stimulation, the agency announced Friday (June 7).
Lawyers in the gene therapy field said FDA’s approval of AveXis’ Zolgensma, a new drug for treating spinal muscular atrophy (SMA), lays the groundwork for an expected wave of future gene therapy drug applications.
As all eyes are on Oklahoma’s trial against drug maker Johnson & Johnson over its role in the opioid epidemic, the number of states filing charges against opioid makers is stacking up.
FDA on Monday (June 3) announced a pilot program call center at its oncology office that is meant to serve as an information hub for physicians treating patients with cancer who seek access to unapproved therapies.
Sen. Kirsten Gillibrand (D-NY), a 2020 presidential contender, announced that if elected she would immediately deschedule marijuana as a controlled substance to pave the way for investment in research for medicinal applications.
The House Appropriations Committee approved a 2020 funding bill on Tuesday (June 4) that would give FDA a $184 million boost over 2019 levels. During the markup, lawmakers voted to restore language featured in previous bills that would prevent the genetic modification of human embryos.
The House on Tuesday (June 4) passed by voice vote the Senate’s pandemic preparedness bill, which does not include a measure to reform FDA’s over-the-counter (OTC) drug regulatory framework that was part of the House’s original pandemic bill.
© 2002-2024. Inside Washington Publishers | Contact Us