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FDA and EMEA inspections

July 13, 2009

Analysis of:Obama healthcare budget includes FDA reform | www.reuters.com

cGMP inspections by FDA and EMEA. FDA inspection was definitely inferior.

Biotech the big driver?

July 5, 2009

Analysis of:Biotechnology can be the next big driver for the pharma sector | www.dnaindia.com

Generic biologicals Patent expiration Kenneth Cleaver, Ph.D.

P.A. in an Endocrinology Practice

February 9, 2009

Analysis of:Quality of Diabetes Care in Family Medicine Practices: Influence of Nurse-Practitioners and Physician’s Assistants | www.annfammed.org

From my experience, Physicians Assistants have a closer relationship with the patient and are much more knowledgable about medical technology. After the P.A. left my doctor's practice and was not replaced, I am considering looking for another doctor.

Comparison of XYZAL to Hismanal (Astemizole)

June 1, 2007

Analysis of:FDA Approves XYZAL(R) (Levocetirizine Dihydrochloride) Tablets For The Relief Of Seasonal And Year Round Allergies, And Chronic Hives | www.medicalnewstoday.com

Hismanal (R), approved by the FDA in the mid 1980's for the same indications as XYZAL, had similar properties (efficacy with one daily dose, low sedation, long elimination half-life, warning about dosing to renally impaired patients). Hopefully, long-term studies with XYZAL will show neither unacceptable accumulation of parent compound or any metabolite, nor the development of any unacceptable adverse events, which was astemizole's fate, leading to it's withdrawal from the market. As Director of Clinical Research for Janssen Pharmaceutica during most of the deveopment of astemizole, I was very aware of the priorities which were necessary to attain approval of the desired claims, but probably not as cognizant of the long-term potential problems which needed to be studied. Hopefully, UCB and Sanofi-Aventis will be diligent in their pharmacovigilance studies. Kenneth E. Cleaver, Ph.D.

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