FDA Government Leads Pharmaceutical manufacturing 
European Pharmaceutical Review
JANUARY 9, 2024
Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Integrative Analysis of Multi-Omics Data with Deep Learning: Challenges and Opportunities in Bioinformatics.
European Pharmaceutical Review
SEPTEMBER 29, 2022
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Clarify Health
OCTOBER 26, 2021
Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American.
European Pharmaceutical Review
JULY 21, 2023
Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.
pharmaphorum
NOVEMBER 25, 2022
The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. The challenge facing the pharmaceutical industry today though, he said, is to go beyond the standards of care, and improve drugs to make them safer and more effective.
pharmaphorum
OCTOBER 26, 2022
The status isn’t awarded lightly and Chiesi is the largest pharmaceutical manufacturer to be named a B Corp. “We As a result, society and government bodies have not developed models and policies that adequately support the development of and access to rare disease drugs.”. About the author.
World of DTC Marketing
DECEMBER 10, 2020
Among the 25 worldwide companies that spend the most on research and development—all more than $5 billion a year—seven are pharmaceutical manufacturers, but eight are automobile or automobile-parts companies with profit margins under 10 percent. years to win FDA approval, at a median cost of $648 million.
Expert insights. Personalized for you.
122 
Let's personalize your content