Jill Wechsler

The American Society of Mechanical Engineers' Council on Codes and Standards established an ad hoc committee to examine whether a standard to create uniformity and consistency in the bioprocessing industry is needed. This article describes the goals and current activities of the standards committee and its subcommittees.

FDA relies on e-chips to thwart bogus products, and drops paper pedigrees and unit-of-use packaging.

FDA is expanding electronic data submission programmes to improve regulatory operations, and ensure appropriate and safe drug use.

This year has been one of tremendous activity at the US Food and Drug Administration (FDA) and other government agencies involved with health care, biomedical research and national security. Scientists completed sequencing the human genome, setting the stage for a period of important new medical therapy development. Efforts to protect the nation from biological warfare created pressures to produce new vaccines and medical treatments able to counter biological, chemical and radiological attacks (see sidebar "Combating bioterrorism").

The US Food and Drug Administration is working with manufacturers to establish new policies for incorporating genomic information into the regulatory process and simultaneously encourage pharmacogenomic research.

Regular update from Washington.

The US Food and Drug Administration is making changes in inspection processes, post-approval manufacturing changes and 21 CFR Part 11 policies to streamline oversight and improve product quality.

As the US Food and Drug Administration (FDA) strives to streamline its regulatory process for bringing new drugs to market (see sidebar "Manufacturing data key to spurring drug development"), efforts to ensure the quality, safety and efficacy of dietary supplements and herbal medicines are gaining more attention.

Progress in developing AIDS vaccines is focussing attention on the challenges involved in producing millions of doses for developing nations.

Efforts to establish a Medicare pharmacy benefit programme will affect drug pricing and policies that shape industry research and development.