Compliance Licensing Reagent Regulation 
pharmaphorum
SEPTEMBER 29, 2022
The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.
Drug Discovery World
JANUARY 30, 2024
High-cost materials: Specialised equipment, reagents, and cell culture media significantly contribute to the overall cost. Intellectual property: High patent royalties and licensing fees for key technologies can inflate treatment costs. Automating and scaling up manufacturing is crucial for cost reduction.
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FDA Law Blog
AUGUST 3, 2022
Thirty years ago today, FDA announced that it had the authority to regulate you. If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. By Jeffrey N. Gibbs & Allyson B. 92P-0405 (Aug.
FDA Law Blog
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
The Pharma Data
DECEMBER 23, 2020
based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation.
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