Search results for " regulators" in Articles / App Notes
Article
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
Brazil Emerges as Global Biopharm Collaborator
Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.
The pharmaceutical market in Brazil has been growing steadily and strongly in the past five ye…
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FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
Article
Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
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Elucidating Biosimilars Characterization
In recognition of this inherent variability, regulators have determined that a unique pathway is required for the testing and registration of biosimilar medicines.
NIBRT: Differences regarding the…
Article
Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear.
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new…
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
Quality Considerations for Using AI in Bio/Pharma
The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization ser…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
Article
Getting your investigational drug regulatory ready
From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline …