Post-marketing study
This article was originally published in The Tan Sheet
Executive Summary
FDA has awarded consulting firm Booz Allen Hamilton a $1.1 mil. contract to "examine in-depth the agency's internal process regarding [post-marketing commitments] and make recommendations regarding ways to improve our PMC process and practices," the agency announces April 5. Results from the study are not expected to directly affect existing Phase IV commitments, according to FDA. The study, slated to begin in April, will likely take one year to complete and will "evaluate the consistency of the process within FDA divisions and across Centers for requesting and reviewing" PMCs, Booz Allen said. The agency said it will help facilitate the study and provide feedback to Booz Allen on submitted draft reports before they are finalized. FDA said in February that it plans to retain a contractor to recommend improvements to the Phase IV commitment process. Many industry observers have noted that the increased importance of post-marketing commitments will likely play a part in product approval decisions due to drug safety concerns...
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.