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Results for: Hear From the Experts - Regulatory
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25 Years of Regulation - and Still Failing - Risky Business, Chapter 4
February 2, 2011
Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness. -
Communication Strategies for Risk Minimization
July 12, 2010
In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product -
Generic Drug Approvals in the US Prior to the Hatch-Waxman Act
July 12, 2010
It is a common misconception that the Hatch-Waxman Act of 1984 created the generic drug approval process in the US. A recent article claimed there were -
The Evolution of Oncologic Drug Development
July 8, 2010
Despite a doubling in the number of candidates in the cancer drug pipeline from 1990 through 2006, the overall US approval rate for cancer drugs -
FDA Requirements for Clinical Studies in Pediatric Patients
July 7, 2010
Differences in the physiology of adults and children can produce significant differences in the way they respond to drugs and vaccines. Without adequate data on pediatric -
On the Origin of the Animal Rule
July 7, 2010
New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -
Key Challenges to US Topical Ocular Drug Development
July 7, 2010
This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development. An understanding of ophthalmology -
Follow-on Biologics in the EU & US
July 7, 2010
Follow-on biologic (FOB) is the generally accepted terminology, although “biogeneric” is often favored by the generic drug industry. European and Canadian regulatory agencies refer to -
CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics
July 7, 2010
This article summarizes some of the issues pertaining to biosimilars in Europe that are also likely to impact eventual FOB approval testing in the US. -
Geoff Garabedian
March 25, 2009
As Practice Leader for Regulatory and Quality in the U.S., Geoff combines a strong management consulting background with specific experience in the regulatory and compliance arena, including design and implementation of large-scale process, organization and technology transformations.
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