Executive Briefing Series (formerly The Food & Drug Letter)

The FDA now regulates more than 150,000 drugs and medical devices — far more products than ever before, as well as more complex products.

Pharmaceutical firms need to start building quality into their products and eschew the idea that testing alone can be relied upon to ensure product quality -- that's the philosophy of the FDA's draft guidance on implementing a quality systems approach to drug manufacturing.

Clinical sites using computerized systems in their trials should rely on the standards outlined in the predicate rules, rather than those listed in 21 CFR Part 11, according to a new guidance issued by the FDA.

Companies that manufacture single-entity or co-packaged combination products must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released as part of the FDA’s pharmaceutical cGMP initiative.

Limiting the exposure of sterile product elements, maintaining the highest degree of environmental control, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.

Drugmakers should use cutting-edge scientific and engineering knowledge, coupled with the best principles of quality management, in their manufacturing process to respond to the challenges of new discoveries and ways of doing business, the FDA said in a final guidance on process analytical technology (PAT).

Determining the extent to which the FDA monitors drugmakers' postmarketing study commitments and evaluating how drug firms compute the average sales price (ASP) for drugs reimbursed under Medicare are among the investigations HHS' Office of Inspector General (OIG) plans to undertake in fiscal 2005.

HHS will hold a public meeting Nov. 8 to weigh new ideas and promote new solutions to speed the development of effective new drugs and biological products.

House and Senate lawmakers have introduced legislation that would mandate registration of clinical trials for human drugs, biologics and medical devices at an existing NIH online database, as well as restrict the use of study data in promotional materials for sponsors that don't register their trials.