By Jamie K. Wolszon & Jeffrey N. Gibbs – As 2015 draws to a close, the world of laboratory-developed test regulation continues in high gear. One major event featured the Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren testifying last month before the House …
By Kurt R. Karst – Last week we posted on one of two bills recently introduced in Congress that continues a trend to push for (or reward) new product development by offering an incentive different from the standard grants of patent and non-patent marketing exclusivities (S. 2055, the …
By Jamie K. Wolszon & Jeffrey N. Gibbs – As kids around the country return to school, FDA also appears to be returning from a break—in this case a break from public enforcement-type activities related to laboratory-developed tests (LDTs)—with the issuance of a letter to Pathway …
By Jamie K. Wolszon – As we have previously blogged on numerous occasions, FDA has released a framework for regulation of laboratory-developed tests (LDTs) that has sparked considerable controversy. The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant in …
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the …
By Allyson B. Mullen & Jeff N. Gibbs – As we have previously blogged on numerous times (for example, here and here), FDA has released a framework for regulation of laboratory developed tests (LDTs). FDA’s proposed framework has sparked much controversy, receiving support from diagnostic test …
By Jamie K. Wolszon – Amidst the winter storms that have struck the East Coast this January and February, there has been, and will continue to be, a flurry of developments related to FDA efforts to actively regulate Laboratory-Developed Tests (LDTs). Those developments include a White …
By Jamie K. Wolszon & Jeffrey N. Gibbs – The House Energy & Commerce Committee, which has jurisdiction over FDA, has issued a “white paper” announcing that as part of its efforts to prepare a draft discussion legislative package in early 2015 related to the overall …
By Jamie K. Wolszon & Jeffrey N. Gibbs – On November 6, Alberto Gutierrez, the head of the office in charge of regulating in vitro diagnostics at FDA’s Center for Devices and Radiological Health (CDRH), discussed the two Laboratory-Developed Test (LDT) draft guidances with members of …
By Allyson B. Mullen & Jeff N. Gibbs – On October 23, 2014, CDRH held a webinar regarding the two Laboratory Developed Tests (LDT) draft Guidance Documents that were released on October 3 (previously blogged on here and here). The webinar began with a high-level description of …
By Jeffrey N. Wasserstein – On July 2, 2014, five U.S. Senators sent a letter to the head of the Office of Management and Budget (“OMB”) urging OMB to release a draft guidance proposed by the U.S. Food and Drug Administration (“FDA”) relating to the regulation …
By Jamie K. Wolszon – In the past two months we have seen two newsworthy items in the Laboratory-Developed Test (“LDT”) world. In June, the Defense Health Agency (“DHA”) announced that TRICARE, the U.S. health care program serving Uniformed Service members, retirees and their families, has …
By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”). FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014). The 2014 Guidance replaces the final …
By Allyson B. Mullen & Jeffrey N. Gibbs – On November 25, 2013, CDRH issued the Final Guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” (the “RUO Guidance”) (see our previous posts on the draft …
By Allyson B. Mullen – For many individuals, a diagnosis, be it life threatening or chronic, is scary. However, the trial and error process that can follow the diagnosis in order to find a therapy (e.g., drug, device and/or biologic) that works best for the patient …
