Remove 2027 Remove Pharmaceuticals Remove Pharmacokinetics
article thumbnail

Where is the promise for plant-based medicines? Part 1: Cannabis  

Drug Discovery World

Michael Sassano, CEO at SOMAÍ Pharmaceuticals, shared with DDW that it is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estimated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 5.

article thumbnail

Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Agency IQ

GDUFA III), which reauthorized the program through 2027. The first hypothetical involved a topical gel product with two active pharmaceutical ingredients (APIs). The generic drug user fee program is currently on its third iteration (i.e.,

Science 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Breakthrough drug candidates and cancer treatment innovations

Drug Target Review

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

Treatment 100
article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA 40