Regulatory Articles

Employees must understand the nature of the business they are in, the level of regulation that applies, and the consequences of noncompliance

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Process variations inevitably result in change, and change may mean new regulatory hoops. Statistical quality control is a cost-effective and efficient method for coping with change while still remaining compliant with 21 CFR Part 58.

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Medical Law and Research includes chapters o­n the following topics: liability in clinical research; trial approval and regulatory affairs; confidentiality; informed consent (including children and vulnerable subjects); negligence; misconduct and fraud; and publications.

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FDA’s draft guidance o­n aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

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In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.

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Even if FDA does not require pharma companies to co-market a diagnostic test, insurers and health plans may pressure industry to do so, according to Robert Temple of CDER.New knowledge of genetic biomarkers for disease is spurring development of pharmacogenomic (PG)-based drugs and biological products and raising new challenges for FDA and manufacturers. Genomics information promises to spur discovery of more individualized treatment regimens by identifying patients most likely to respond to certain medicines — as well as individuals more susceptible to adverse events.

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Paper notebooks are the accepted method for recording laboratory data and the ideas generated from that information in the pharmaceutical, biotech, and chemical industries. Nonetheless, the revolution in digital data processing has improved the way data is created, organized, and managed electronically, whether in the form of analytical data, images, documents, or multimedia files. The preservation of such information into a digital form offers the potential for online storage and retrieval, efficient search processes, and worldwide data transmission.

understandable tendency to think of it as a reference book—indeed, its size (
3000 pages in the 2004 edition) and tenure (continuous publication since 1820) recommend it for this purpose. Yet the truth is that USP–NF has been under continuous revision by its users since itsinception at the first pharmacopeial convention in the nation’s capital. Users in industry, government, and academia can submit requests for revision of the public standards in the compendia and, in fact, are the very source of the monographs that are published in USP–NF. Contrary to widely held public perceptions, USP does not unilaterally establish drug standards without public input.

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It seems hard to fix the nation's vaccine supply problems. The flu vaccine shortage of last fall turned into a surprising surplus by January, as confusion and delays discouraged millions of Americans from lining up for a shot. Centers for Disease Control and Prevention (CDC) director Julie Gerberding cited "unprecedented supply-and-demand mismatches" at the local level as she encouraged broader distribution of more than five million unused vaccine doses before the flu season ends. The future doesn't look very bright, though, as doctors and manufacturers remain uncertain about who will produce flu vaccine for next year, what the supply will be, and who will want treatment.

Mass spectrometrists working in pharmaceutical 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 co-author 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.”

There are two schools of thought that conflict over what constitutes effective regulatory compliance. One abides by the methods FDA favoured for many years. The other prefers a retrenched view, one more closely informed by the original objective of ensuring good scientific practice.