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.
The House Judiciary Committee will mark up four bills on Tuesday (April 30) that would give the Federal Trade Commission more power to crack down on abuses by brand and generic drug makers that lead to higher prescription drug prices, including the CREATES Act and pay-for-delay legislation.
Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.
A leading pediatric neurologist said he welcomed FDA’s approval of the first-ever device for treating attention-deficit/hyperactivity disorder (ADHD).
FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.
As FDA works to develop an agricultural water rule as a part of its obligations under the Food Safety Modernization Act (FSMA), one consumer advocate said the agency could learn a thing or two from new agricultural water safety standards recently approved by the California Leafy Greens Marketing Agreement (LGMA).
FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).
A month after reporting it received tens of thousands of adverse events associated with surgical staplers and staples, FDA is stepping up its regulation of the devices by: issuing a proposed order to upclassify the Class I devices as Class II; issuing draft guidance on labeling recommendations to ensure adequate use; and scheduling a public meeting on May 30 to gather input on the first two efforts.
FDA and Duke University’s Robert J. Margolis, MD, Center for Health Policy will host a meeting May 16 to gather input on how to apply the agency’s benefit-risk framework throughout the human drug lifecycle and how to communicate information relating to benefit-risk assessments.
In the wake of a 35-day partial government shutdown that furloughed 41 percent of the agency’s staff earlier this year, a group of FDA policy experts sent a letter to the agency asking for more details on how much funding FDA had and from what sources; exactly how many personnel were exempted, excepted and furloughed throughout the shutdown; and how FDA is preparing for future shutdowns.
As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.
© 2002-2024. Inside Washington Publishers | Contact Us