FDA gets job of setting up genetic test criteria
This article was originally published in Clinica
Executive Summary
An interagency group has decided to give the FDA full responsibility for coming up with a regulatory scheme for reviewing genetic tests. The Secretary's Advisory Committee on Genetic Testing (SACGT), a public-private advisory panel established in 1999 to advise the Secretary of Health and Human Services (HHS) on a variety of policy issues regarding genetic testing, had initially sought a new classification algorithm for these tests that would have set genetic testing apart from other forms of diagnostics.
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.