Regulatory
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Nutra Pharma receives regulatory approval to market Nyloxin in India
Nutra Pharma has received approval in India for its Nyloxin line of pain relievers.
Regulatory | 11 August 2011
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AstraZeneca's NEXIUM receives first regulatory approval in Japan
AstraZeneca announced that NEXIUM (esomeprazole magnesium) 10 mg and 20 mg capsules have received regulatory approval in Japan for the treatment of acid-related conditions including non-erosive reflux disease (NERD), reflux esophagitis, and peptic ul…
Regulatory | 01 July 2011
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PharmaNet offers guidance on regulatory pathway for biosimilars development
PharmaNet is offering guidance on the regulatory pathway for biosimilar development in the United States, following a FDA hearing. The two day public hearing aimed to obtain input from interested stakeholders on specific issues and challenges as…
Regulatory | 11 February 2011
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Regulatory Compliance of Equipment Qualification
With the majority of API being produced in Asia for Western pharmaceutical companies, compliance with current GMP regulations has become a topic of great importance for Asian drug manufacturers. This article looks at the regulatory compliance in the qualification of laboratory testing equipment.
Regulatory | 01 June 2010
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RAPS Selects ForeignExchange for Regulatory Affairs Translation
The Regulatory Affairs Professional Society (RAPS) has selected ForeignExchange Translations to translate the former’s Fundamentals of Japanese Regulatory Affairs handbook. RAPS publishes books that help regulatory professionals navigate the la…
Regulatory | 25 February 2010
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Glycotope Receives Regulatory Approval for Cancer Study
Glycotope, a German Biotech company, has received regulatory approval by German and Italian regulatory authorities for a Phase I study of its lead antibody GT-MAB 2.5-GEX for the treatment of various solid cancers. The approvals indicate the suit…
Regulatory | 04 December 2009
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Good Products Selected by FDAS for Regulatory Inspection
Good Products, a provider of enterprise content management solutions for the pharmaceutical and biopharmaceutical industries, has announced that its g-docs Electronic Document Management Solution has been selected by Food and Drug Analytical Services…
Regulatory | 26 November 2009
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Astrazeneca Withdraws Regulatory Submissions for Cancer Drug
AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), from the US Food and Drug Administration (FDA) and the Europ…
Regulatory | 12 November 2009
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Novatek: Process Control
Novatek International provides pharmaceutical, biopharmaceutical, biotech and chemical companies with regulatory compliant (process-based software) solutions. The company’s suite of laboratory and quality management solutions offer quality managem…
Regulatory | 01 November 2009
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Managing Cold Chain Storage and Distribution
The process of transporting temperature sensitive pharmaceutical products involves the consideration of various factors that range from warehousing to regulatory compliance.
Regulatory | 01 August 2009
