A rule forcing the FDA and other agencies in the U.S. Department of Health and Human Services (HHS) to evaluate and clean out old regulations will never see the light of day.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Biomind, Clearmind, Cynata, Hyundai, Innocare, Janssen, Merck, Pfizer, Reata, Revive, Roche, Scisparc, Servier.
The U.S. FDA has received a citizen’s petition regarding the use of neuropsychological testing prior to placement of a deep brain stimulation (DBS) device for treatment of Parkinson’s disease. The petitioners, most of whose names were redacted, said that there is no standardized test for this purpose, and thus the patient should have sole discretion of evaluating the meaning of their own tests or the use of these tests should not be seen dispositive of the question of whether to go ahead with placement of a DBS device for Parkinson’s.
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
Ignoring congressional sentiment, U.S. Health and Human Services Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health as an independent entity within the NIH.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lumiradx, Nexus Medical Labs, Rhinostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Cornerstone, Elevation, Jaguar, Medac, Medexus, Oncotelic, Phathom, Verrica.
The mutual recognition agreement between Switzerland and the EU for medical devices lapsed in 2021, a development that was expected to add a significant amount of drag on Swiss device exports to EU nations.
Organ transplant diagnostic company Caredx Inc. has received CE marking for its Alloseq HCT chimerism testing kit and Alloseq HCT interpretation software for use in patients who have received hematopoietic cell transplantation (HCT). The NGS-based solution is used to monitor engraftment and evaluate the success of a hematopoietic stem cell transplant by measuring the relative ratio of the recipient and the donor cell population post-transplantation.
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
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