General Stim Inc.’s implanted sacral nerve stimulation (SNS) system was approved in China to treat individuals with certain bladder and bowel conditions. Hangzhou-based General Stim’s SNS system consists of a sacral nerve stimulator, an extension lead and an electrode.
The U.S. FDA’s citizen’s petition process doesn’t always yield the desired outcome, but the agency must nonetheless respond to these petitions. Sonex Health Inc., has petitioned the FDA to rethink a proposal to reclassify the company’s SX-One device for treatment of carpal tunnel syndrome, an unusual instance in which a medical device maker has resisted a proposal to make a device exempt from regulatory requirements.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cutera, Vielight.
The French government is officially launching a major national program for digital health. This priority research program and equipment (PEPR) in digital health is being piloted by two major government research bodies, the National Institute for Health and Medical Research (INSERM) and the National Institute for Research in Digital Science and Technology (INRIA). It has a budget of $65 million over seven years
A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Alentis, Eagle, Ipsen, Paxmedica, Pepgen.
In their continuing battle against high prescription drug prices, U.S. lawmakers are firing yet another volley at the middlemen – this time to delink their administrative fees from drug prices. Several members of the Senate Finance Committee, including the leadership, introduced the bipartisan Patients Before Middlemen Act June 14 with the intent of wrapping it into a larger drug pricing legislative package the committee plans to complete over the next few months.
A higher rate than expected of serious bleeding, including five deaths, in ovarian cancer patients receiving upifitamab rilsodotin (UpRi) led the U.S. FDA to place a partial clinical hold on two trials, possibly delaying Mersana Therapeutics Inc.’s BLA filing targeted for later this year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Can-Fite, Ferring, Highfield, Ironwood, Starton, Stealth.
As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain.
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