Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acurx, Biosyngen, Boan, Bone, HRA, Nova Mentis, Regenxbio, Sarepta, Takeda, Telix, Vertex.
The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moximed, R2 Technologies, Reach Neuro.
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the World Health Organization (WHO) is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions so the treatments can be used where they’re needed most.
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Can-Fite, JW, Merck, Moderna, Promis, Sumitomo.
In December 2013, the U.S. FDA held an advisory hearing on spinal spheres used in intervertebral fusion procedures, a hearing that generated a recommendation that the agency classify these devices as class III devices. The agency finally followed through on that recommendation with a final rule that requires a PMA filing for these devices, concluding a process that took much longer than the typical rulemaking.
The International Medical Device Regulators Forum (IMDRF) has posted a guidance that spells out the use of a common document for regulatory review for member regulatory authorities, a mechanism that might ease the lives of manufacturers across the globe.
Hundreds of executives from biopharma companies are signing onto an April 10 letter decrying a U.S. district judge’s decision last week to stay the FDA approval of mifepristone, which is used in more than half of all abortions in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Brim, CNS, Enanta, Everest, Merck.
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