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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
House Energy & Commerce Health Subcommittee Advances 21 Bills. The markup included legislation around telehealth, Medicaid, workforce and rare diseases. Of note, the subcommittee advanced a bill that included an extension of...more
Both chambers of Congress are out of session today and return for the rest of the week. Most healthcare priorities remain out of the congressional spotlight this week, but telehealth is still top of mind. As we...more
Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more
After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more
On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more