Audits and Inspections

Drug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

There are several considerations to keep in mind when auditing an outsourcing provider.

After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

The FDA issued MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved.

FDA's approach involves adopting efficient strategies for targeting inspections to more high-risk operations likely to have the greatest impact on public health.

FDA is working more closely with foreign regulators to keep abreast of drug and vaccine quality issues in their regions.