Search results for " global harmonization"
Article
Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
Article
Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
Article
Report from the 12th Plasma Product Biotechnology Forum
Since the first meeting in 1999, the PPB forum has established itself as the key international forum for the plasma manufacturing industry – read our report for the highlights of the 2022 conference…
Article
Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…