Search results for " regulations" 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…
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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
While producers of food products and fine chemicals have engineered precise controls that yield defect-free products, she finds that pharmaceutical companies focus more on complying with regulations. …
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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
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
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…
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Quality by design for biotechnology products—part 1
Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
4. US FDA. Guidance for industry: PAT—A framework for innovative pharmaceutical developm…
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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
Regardless of the indication or program, Kellerhals emphasizes that quality systems and regulations are universal and overarching, and adherence to strict quality standards is essential to ensure cons…
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Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…