Regulatory Articles

Washington, DC-A new advisory committee appointed by HHS secretary Tommy Thompson will scrutinize agency policies to identify ways to improve programs and regulations. Mayo Clinic cardiologist Douglas Wood heads the 27-member panel, which includes representatives of health plans, hospitals, providers, and Genentech chief medical officer Susan Desmond-Hellman. The group will focus o­n Medicare and Medicaid as well as FDA activities. At the first meeting, FDA senior associate commissioner Bill Hubbard outlined several key programs in need of "reinvention":

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The authors propose several models for independent evaluation of new excipients


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The European Union requires final container testing of US-manufactured biopharmaceutical products to be performed in Europe for release into the European market. Similarly, but less strictly enforced, the US requires final container testing in the US for European-manufactured biopharmaceutical products before release.

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The ability to compete globally is essential to success in the pharmaceutical industry. The current trend is to establish joint ventures, outsource various stages of the development and production of a single pharma product, and purchase or start an indigenous business in other countries. Successful companies have also moved beyond mere exploratory attendance at trade shows to gain familiarity with foreign markets and environments that are sometimes very different than their "home field." Executives sophisticated in handling cultural distinctions and regulatory nuances have a distinct advantage. (See "Culture Clashes," page 76.)

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flexibility of the myosin head was measured using phosphorescence anisotropy of selectively labeled parts of the molecule. Phosphorescence anisotropy was measured in soluble S1 and myosin, with and without F-actin, as well as in synthetic myosin filaments. The anisotropy of the former were too low to observe differences in the domain mobilities, including when bound to actin. However, this was not the case in the myosin filament.

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Abstract

Increasing resistance to antimicrobial agents is of growing concern to public health officials worldwide. The concern includes infections acquired in hospitals, community infections acquired in outpatient care settings, and resistant foodborne disease associated with drug use in food-producing animals. In the United States, a significant source of antimicrobial-resistant foodborne infections in humans is the acquisition of resistant bacteria originating from animals. The US Food and Drug Administration’s (FDA’s) goal in resolving the public health impact arising from the use of antimicrobial drugs in food-producing animals is to ensure that significant human antimicrobial therapies are not compromised or lost while providing for the safe use of antimicrobials in food animals. The FDA’s approach to the problem is multipronged and innovative.

Rising healthcare costs and the pressure to expand medical coverage focus public attention o­n medicine outlays.

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When did retail pharmacy, and, more specifically, the art and professionalism of dispensing a prescription become a commodity? I'm sure every retail pharmacist has a different answer depending o­n how new he or she is to the profession; I know I do. For me, it was back in 1969, when I was just fresh out of school, thinking that pharmacy was the greatest profession in the world. The store I interned in had its fair share of indigent patients who got their prescriptions filled o­n what was then a small federal government program known as Medicaid.


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Change is in the air for European regulations. Formal legislative proposals might not appear until 2002, but the shape of the changes is beginning to become clear

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Tom Cupps,Betsy Fritschel,Wendy Mavroudakis,Michael Mitchell, Dave Ridge, and Jean Wyvratt The PhRMA API Technical Group examines topics concerning active pharmaceutical ingredient development and manufacture and makes recommendations for regulatory guidance.


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