The Lyme Disease Association announces that the Food and Drug Administration (FDA) yesterday cleared for marketing four previously cleared tests for the diagnosis of Lyme disease. Called the modified two-tier, enzyme immune assay, (EIA), the new tests are able to be run at the same time or sequentially. The current two-tier testing has an EIA […]
On January 22, 2002 in Bethesda, MD., the LDA was able to get a private meeting with the FDA on the vaccine issue, despite reluctance by the FDA to grant the meeting. Congressman Chris Smith helped facilitate the setup of this meeting. On February 25, 2002, a month after meeting with FDA, LDA received written […]
This is an FDA powerpoint by Robert Ball, M.D., M.P.H., Sc.M., on the Lymerix Vaccine, LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS), January 31, 2001. Robert Ball, M.D., M.P.H., Sc.M., Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), Rockville, […]
Signons from Lyme Group Leaders on FDA Test TakeoverThe Lyme Disease Association, Inc. (LDA) has formulated a response to FDA to be included in its comment period on its testing Guidance which will affect specialty lab Lyme tests. Therefore, groups who want to support the position taken by the LDA may join in on the […]
FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under […]
Time Sensitive Survey: The Food & Drug Administration (FDA) is poised to develop new regulations which may affect access to existing tests for Lyme and other tick-borne diseases. Please click on the link to complete a survey being done by LymeDisease.org, an affiliate of the Lyme Disease Association. The information is needed for upcoming meetings […]
REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, MAY 21, 2002. Why more adverse events were seen after the vaccine reached the market: People receiving Lymerix after product launch lived in Lyme-endemic areas. REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE […]
SPECIAL REPORT: LDA MEETS WITH FDA ON LYMERIX On January 22, 2002 in Bethesda, MD., the LDA was able to get a private meeting with the FDA on the vaccine issue, despite reluctance by the FDA to grant the meeting. Congressman Chris Smith helped facilitate the setup of this meeting. Patricia Smith, President, Lyme […]
I am here today because we do favor a safe and effective vaccine, but we are unsure whether an OSP A based vaccine can meet those criteria. Since the inception of OSP A vaccine trials, we heard from individuals experiencing difficulties after immunization. The information was startling, not only because of the problems described, but […]
Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease July 7, 1997 Purpose FDA is advising you about the potential for misdiagnosis of Lyme disease. The results of commonly marketed assays for detecting antibody to Borrelia burgdorferi (anti-Bb), the organism that causes Lyme disease, may be […]