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| Compliance Column 2004 Archive |
Twice a month, the P.I.L.S. Compliance Columnist, Fiona Jones, explores the complex issues and strategies driving global compliance in all areas of the pharmaceutical industry.
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December 16, 2004
This edition of the P.I.L.S. Compliance Column takes at look back at some of the topics covered in 2004 and what may be ahead for the compliance community in 2005.
...full story
November 29, 2004
This edition of the P.I.L.S. Compliance Column takes at look at the World Health Organization’s groundbreaking report recommending ways in which pharmaceutical research and innovation can best address health needs and emerging threats in Europe and the World. The report highlights diseases which pharmaceutical innovation should deal with better and the report authors urge the European Union to play a global leadership role in public health.
...full story
November 10, 2004
It has been a tough year for the pharmaceutical industry and the FDA. Before the dust settled from one scandal another appeared on the horizon. Criticism over the handling of drug safety issues has led Dr. Lester M. Crawford, Acting FDA Commissioner, to announce a five-step program aimed at improving its method of risk assessment for approved drugs.
...full story
October 25, 2004
Earlier this month, the FDA issued a Public Health Advisory announcing a multi-pronged strategy to warn the public of the increased risk of suicidal thoughts in children and adolescents being treated with antidepressants.
...full story
October 12, 2004
Merck suffered a huge blow recently when it announced the largest voluntary drug recall in history after a study confirmed that rofecoxib (marketed as VIOXX, Foldox and Meoroxx ) raises the risk of heart attack and stroke. While it may be tempting to simply take two aspirin and hope the pain of the VIOXX withdrawal will go away, now is the time for us all to review our role in the drug development process.
...full story
September 24, 2004
It has become clear that pharmaceutical companies are going to have to publicly register their clinical trials and be more forthcoming with the results – both good and bad! With around 350 registries already in existence, where, when and how will this data appear?
...full story
September 13, 2004
It’s hard to turn on the TV or look at a magazine these days without seeing an advertisement extolling the virtues of some new wonder drug and challenging you to ask your doctor if the drug is right for you.
...full story
August 23, 2004
At nearly every major merger announcement, executives state that laboratory synergies and the need to strengthen product portfolios by plugging pipeline gaps are major driving forces behind the deals.
...full story
August 9, 2004
There is mounting concern in the industry that basic research is not resulting in safe and affordable products reaching patients quickly enough.
...full story
July 20, 2004
Federal health officials have released updated guidelines on cholesterol management advising physicians to consider new, more intensive treatment options for people at high and moderately high risk for a heart attack.
...full story
July 8, 2004
Quality systems are not new to the pharmaceutical industry and most companies will be familiar with cGXP and ISO 9000. However, before dismissing Six Sigma as just another quality system, and throwing all that promotional literature away, remember that Six Sigma is a set of continual improvement tools.
...full story
June 21, 2004
The third of the new FDA guidance documents, entitled Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, focuses specifically on post-marketing risk assessment.
...full story
June 7, 2004
This issue of the P.I.L.S. Compliance Column concentrates on the second of the recently issued draft guidance documents, Development and Use of Risk Minimization Action Plans and discusses its significance for the compliance community.
...full story
May 17, 2004
This issue of the P.I.L.S. Compliance Column explores “Premarketing Risk Assessment” and FDA recommendations to maximize the information gained from clinical trials.
...full story
May 3, 2004
FDA identified efficient risk management as the primary way to make the most effective use of resources and address the challenges of public-health protection.
...full story
April 19, 2004
The pharmaceutical industry is among the most heavily regulated -- and rightly so.
...full story
April 5, 2004
It is perhaps most appropriate to begin at the beginning and explain the origins of modern-day regulation in the industry.
...full story
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