The U.S. FDA’s final report for the software pre-certification (pre-cert) pilot program for software as a medical device (SaMD) highlighted a number of both positive and negative developments, but the agency reiterated its call for new statutory authorities for review of SaMD. However, the agency also acknowledged that the pilot was itself compromised by the absence of that statutory authority because the absence of such authority means that the results of these mock product reviews cannot be legally walled off from non-pilot applications.
CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push.
A serious adverse event (SAE) in one participant has led the U.S. FDA to place a partial clinical hold on Avidity Biosciences Inc.’s lead program. The action is centered on the phase I/II Marina study of AOC-1001, an antibody oligonucleotide conjugate for treating myotonic dystrophy type 1, the most common form of muscular dystrophy in adults.
As part of its obligations under the 21st Century Cures Act, the U.S. FDA is proposing two new rules to harmonize sections of its regulations on human subject protection and institutional review boards with the revised Common Rule, which provides for the protection of human subjects in federally funded research.
While it continues to deny all kickback allegations raised in a whistleblower suit filed seven years ago, Biogen Inc. agreed Sept. 26 to pay $900 million to resolve claims that it paid doctors in the U.S. to prescribe its multiple sclerosis drugs from 2009 through March 2014.
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions.
Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aqualung, Atea, Catalym, Everest, Pfizer, Y-mabs.
Legislation to reauthorize a number of U.S. FDA user fee programs has once again languished until the 11th hour, but the House and Senate committees of jurisdiction have apparently come to terms over the matter. However, the parties to this deal are characterizing it as a “clean” bill, which suggests that FDA regulation of lab-developed tests (LDTs) and a center of drug manufacturing of excellence will have to wait for another day or – because of the upcoming mid-term elections – most likely another year.
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