March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
European approval of renal cell carcinoma treatment
December 7th 2007The European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), a condition that accounts for more than 80% of the estimated 85000 new cases of kidney cancer diagnosed in Europe every year.
A FDA Perspective on Quality by Design
December 5th 2007Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.
What's Next in: Strategy and Regulation
December 2nd 2007There are at least two major factors that will shape the manufacturing industry as a whole. Daniel Ruppar, Industry Manager (North America) for the Pharmaceuticals and Biotechnology Division of Frost & Sullivan predicts that, due to continued globalization, we can expect to see "growth centers for the industry move to emerging market sectors."
SOCMA Offers Recommendations To Better Foreign Inspection Process
November 16th 2007The Bulk Pharmaceuticals Task Force, an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration?s inspection process of foreign drug- manufacturing facilities.
FDA Commissioner Testifies Before Congress on Foreign Inspection Process
November 8th 2007US Food and Drug Administration Commissioner Andrew C. von Eschenbach testified before Congress last week to outline the agency’s inspection process for foreign drug manufacturers and efforts to improve the agency’s information technology systems.
Congress Focuses on FDA Inspections of Foreign Drug Facilities
November 8th 2007The US Food and Drug Administration’s effectiveness in regulating the manufacture of pharmaceutical products and active pharmaceutical ingredients at foreign facilities was questioned at a Congressional hearing last week. Congress, industry, and government officials weighed in on the issue.
Tech Talk: A Q&A with Oracle's Arvindh Balakrishnan
November 1st 2007The senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward virtualization, among other things. Do you have something to ask Arvindh Balakrishnan? Click here to submit your questions.