Regulatory Articles

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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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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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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FDA's regulation 21 CFR Part 11 o­n Electronic Records and Electronic Signatures provides industry with the requirements that allow electronic records and signatures in computerized systems in place of paper records and handwritten signatures.1

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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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Dissolution testing is critical to measuring the performance of pharmaceutical products in tablet and capsule form. It is a relatively new analytical technique, and equipment modifications and improvements span the decade. This article gives an overview of the apparatuses and procedures used in dissolution testing. It also summarizes the activities of the major organizations and groups that influence dissolution testing standards.

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The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions o­n whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.

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The potential of the biotechnology industry to provide blockbuster products is clearly demonstrated by examples like Enbrel (for the treatment of rheumatoid arthritis in adults and of active polyarticular-course juvenile chronic arthritis), Remicade (for the treatment of rheumatoid arthritis and Crohn's disease), and MabThera (for treatment of stage III-IV follicular lymphoma and CD20 positive diffuse large B-cell non-Hodgkin's lymphoma).

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Active Pharmaceuticals Ingredients Committee of CEFIC.