AMDL readies colorectal cancer test data requested by FDA:
This article was originally published in Clinica
Executive Summary
After its failure last year to gain US 510(k) market clearance for its DR-70 colorectal cancer monitoring blood test, AMDL says it has completed the studies and compiled the data that had been requested by the agency. "AMDL will be requesting a meeting with the FDA to present the data, which we believe is compelling," said the Tustin, California firm's CEO, Gary Dreher.
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.