Regulatory Articles

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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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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Well-planned studies designed to pinpoint additional data are increasingly important as a result of the EU's emphasis o­n added therapeutic value.

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Active Pharmaceuticals Ingredients Committee of CEFIC.

FDA backs e-chips over paper pedigrees and unit-of-use packaging.

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It is not intuitive that scientists, clinicians, and parents would allow the most complex, constantly evolving human beings—the pediatric population—to be treated with unstudied medicines and therapies, while demanding a high level of evidence for therapies for the adult population. Unfortunately, this happened during the recent decades of rapid scientific and therapeutic discoveries. Why would it be acceptable that a population that is growing, developing, and inherently highly variable would not be studied while the more stable, not growing, and less variable adult population would be?

Mass spectrometrists working in pharmaceuticals development tend to approach the issue of regulatory compliance with some trepidation. We know we can’t escape its considerable demands for our time and attention, and we’re willing to act accordingly to ensure that our instruments and procedures comply. Yet it often appears that requirements are expanding in both scope and detail. This month’s coauthor succinctly sums up the issue: “The FDA wants to see quality built into the product at the beginning of the development cycle because quality cannot be ascertained at the end.

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When a firm embarks upon a contract manufacturing relationship with a third party, the questions that inevitably arise are: “Who is ultimately responsible for compliance? And what happens if and when a non-compliant situation arises?” The worst thing that can happen is to confront this question after a non-compliant situation occurs. A firm needs to know, from the beginning, who is responsible for each regulatory component.

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European Commission