120-DAY PMA REVIEW PROCESS FOR WELL-UNDERSTOOD PRODUCTS TO BE TESTED FOR IN VITRO DIAGNOSTICS; PMA SUPPLEMENT DRAFT GUIDANCE DOCUMENT NEARING COMPLETION
This article was originally published in The Gray Sheet
Executive Summary
An FDA proposal for a 120-day fast-track review of premarket approval applications for well-understood products is expected to be sent to manufacturers for comment by the end of November.
You may also be interested in...
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.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.