FDA Law Blog

JULY 23, 2024

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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Pharmaceutical Technology

FEBRUARY 3, 2023

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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XTalks

AUGUST 30, 2022

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.

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The Pharma Data

JANUARY 27, 2021

Each study is planned to be carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of each product. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

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The Pharma Data

JANUARY 3, 2021

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. . +46 7686 650 11. 1 Good Manufacturing Practice. 2 Proof of Concept. 3 Active Pharmaceutical Ingredient. Finnish time. About Nanoform. Nanoform is an innovative nanoparticle medicine enabling company.

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The Pharma Data

NOVEMBER 26, 2020

The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. For investor relations queries, please contact: Henri von Haartman , Director of Investor Relations hvh@nanoform.com / +46 7686 650 11. Finnish time. About Nanoform.

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