Senate Seeks Performance Data From FDA On De Novos, Postmarket Surveillance
This article was originally published in The Gray Sheet
Executive Summary
A Senate panel directs FDA to meets its statutory deadlines for de novo reviews and device risk classifications of devices, and requests data on those programs – as well as for the agency's postmarket device surveillance activities – in a 2017 appropriations bill.
You may also be interested in...
FDA '522' Guidance: 15-Month Deadline To Comply With Postmarket Order
The agency has issued a final guidance on Sec. 522 postmarket study orders about five years after a draft version. In the interim, Congress stipulated a 15-month deadline for companies to start the FDA-mandated studies, a requirement emphasized in the new document.
New Fundings And Goals To Match Raised In Latest MDUFA IV Session
As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”