The U.S. Environmental Protection Agency (EPA) has proposed a new set of requirements for control of emissions of ethylene oxide (EtO), a standard the agency claims will “slash” emissions by 80% per year. The problem for med-tech trade associations is that EPA expects that the abatements be implemented within 18 months, a pace that industry says is too aggressive and could lead to shortages of critical devices and products used in surgeries and other procedures.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avation Medical, Magnolia Medical, Nova Eye Medical.
As an April 15 deadline looms, the U.S. Court of Appeals for the Fifth Circuit is being asked to intervene immediately to keep mifepristone on the U.S. market as an abortion option while legal challenges continue to play out in court.
Briefing documents suggest smooth sailing for Rexulti (brexpiprazole) at the meeting to deliberate an application to expand the label of the compound from Otsuka Pharmaceutical Co. Ltd. and Lundbeck A/S into agitation related to Alzheimer’s disease (AD) dementia. A joint sit-down on April 14 of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee will take up the matter of an add-on indication for Rexulti, a serotonin-dopamine activity modulator for schizophrenia and for the adjunctive treatment of major depressive disorder.
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 WHO is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions.
Pharma companies who choose to take advantage of the EMA’s Prime scheme, which is designed to streamline and accelerate the development and approval process for priority drugs, will now be able to meet with the agency about a year before they file for approval.
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.
RSS
