FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
FDA-lir
Subscribe today for access to
Articles and Reports
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
Already a member? Log in here
Already a member? Log in here
Already a member? Log in here
Already a member? Log in here
Already a member? Log in here
Already a member? Log in here