Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sunrise, Tasso.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exelixis, Gracell, Iaso, Ironwood, Jubilant, Nrx, Ocuphire, Pfizer, Pharmazz, Sairopa.
The U.S. Federal Trade Commission (FTC) has updated a 1998 compliance guidance for health care products, much of which reiterates the provisions of the legacy edition. However, this updated version calls for randomized, controlled clinical trials to substantiate any claims made in connection with medical devices.
To increase transparency at its advisory committee (adcom) meetings, the U.S. FDA is proposing asking guest speakers to voluntarily disclose their financial interests and professional relationships to determine their eligibility to give a presentation at an adcom meeting.
With an eye toward the future, the U.S. Patent and Trademark Office (USPTO) is seeking comment on artificial intelligence (AI) technologies and inventorship issues that may arise as AI takes on a bigger role in innovation.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anavasi Diagnostics, Concept Medical, Hyperfine.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Everest, GSK, Phathom.
It may still be true that a majority of medical devices are manufactured in the U.S., but that doesn’t stop the FDA from dropping a warning letter on facilities located outside the U.S. (OUS). In one of these warning letters, Microvention Inc., of Aliso Viejo, Calif., received a warning letter for its plant in Costa Rica, although the FDA waited until the second week of February to post the Sept. 30, 2022, warning.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Catalyst Orthoscience.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Bellerophon, Medicinova, Mesoblast, Regeneron.
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