FDA Law Blog
JANUARY 4, 2023
The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The Agency also recommended not using substantial manipulations at a clinical site for already released final drug product.
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. appeared first on Drug Discovery World (DDW).
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
The Pharma Data
MAY 4, 2021
The Philippine Food and Drug Administration (FDA) is seeking feedback on interim guidelines on the renewal of current good manufacturing practice (cGMP) clearance of foreign drug manufacturers. . Days after the media reports, CDSCO asked manufacturers and importers of tests and reagents to operate at maximum capacity.
pharmaphorum
SEPTEMBER 29, 2022
Food and Drug Administration (FDA) regulation as a medical device. Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.
The Pharma Data
NOVEMBER 30, 2020
Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. The license from ERS Genomics now enables Vivlion to offer both R&D reagents and screening services to its customers worldwide. CEO of Vivlion.
Pharmaceutical Technology
FEBRUARY 15, 2023
“At the small scale, manufacturing between 1 ml and 10 ml is typically not problematic , but it’s not straightforward to replicate processes and technologies once you want to produce tens of litres of formulations,” says Dr Crowe, who manages a team that develop novel analytical assays related to LNPs and nanomaterials for drug delivery.
Pharmaceutical Technology
FEBRUARY 3, 2023
As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting.
Expert insights. Personalized for you.
59 
Let's personalize your content