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FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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Nonclinical Pulmonary Drug Delivery: Setting Up Your Inhalation Drug Study for Success

Camargo

Interest in the pulmonary route has also grown in recent years because delivering the drugs through the lungs allows direct systemic delivery and bypasses the first pass metabolism. Why is pulmonary drug delivery a complex challenge? How can we accomplish drug delivery to the lungs in nonclinical studies?

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Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer

XTalks

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.

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CordenPharma and Certest forge partnership to enhance drug delivery innovations

BioPharma Reporter

CordenPharma, a global CDMO manufacturing complex drug substances and lipid nanoparticles (LNPs), has signed a partnership agreement with Certest, a Spanish company specializing in drug delivery and API synthesis.

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Transdermal and Microneedle Drug Delivery 2023

pharmaphorum

The 2023 Transdermal and Microneedle Drug Delivery Conference will explore real world applications of microneedles in drug delivery and strategies for advanced and user-centric device design. Regulation of transdermal delivery systems will be another key theme addressed, in combination with clinical trial optimization.

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Oramed inks deal to commercialize oral insulin in South Korea

BioPharma Reporter

Oramed Pharmaceuticals, a company focused on the development of oral drug delivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate.

Insulin 95
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Aptar makes digital health play, agreeing deal to buy Voluntis

pharmaphorum

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.