XTalks
OCTOBER 27, 2021
Genentech’s ocular implant drug delivery system for treatment of macular degeneration has received approval from the US Food and Drug Administration (FDA). Susvimo delivers ranibizumab via a port delivery system into a surgically placed implant in the eye, allowing for continuous delivery of the drug.
Pharmaceutical Technology
OCTOBER 26, 2022
It indicates that nanomedicine also has the potential to combat the threat of antibiotic resistance via the use of nanomaterials with intrinsic antibacterial properties, as well as using nanoparticles as effective drug delivery systems for antibacterial agents.
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FDA Law Blog
JUNE 13, 2024
The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable. While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R.
XTalks
MAY 30, 2023
The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.
XTalks
AUGUST 24, 2022
By the end of this year, the EPA plans to propose an air pollution regulation to address EtO emissions at commercial sterilizers and to protect public health. As a result, the EPA is providing new information on specific facilities where lifetime risk levels are the largest to nearby communities.
pharmaphorum
JANUARY 18, 2022
The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. 08.30 – 12.30.
FDA Law Blog
SEPTEMBER 19, 2023
It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.
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