Federal Reports

The Postal Service is among the top postal operators in digital services that enhance the core letter and parcel business, but it lags behind in terms of revenue-generating pure digital services. Despite legal constraints prohibiting the provision of non-postal services, the Postal Service should fortify its digital strategy. The future postal digital strategy would be based on four building blocks: increasing the use of data to optimize operations and build a more data-rich environment for customers; speeding up the digitization of its "physical" products; rejuvenating its limited portfolio of purely digital services, and accelerating digital transformation.

FDA approves new drugs for sale in the United States through the new drug application (NDA) review process. FDA requires all new drugs to undergo clinical testing to demonstrate their safety and efficacy prior to approval. However, premarket clinical trials may not always identify or fully characterize risks. Postmarketing research can provide additional information about the risks, benefits, and optimal use of an approved drug. In 2006, the Office of Inspector General (OIG) found that FDA could not readily identify whether or how timely postmarketing studies were progressing toward completion, and that FDA lacked an effective monitoring system for postmarketing studies. Since then, the Food and Drug Administration Amendments Act (FDAAA) expanded FDA's authority to require postmarketing studies and to take enforcement action when sponsors are out of compliance. This study follows up on OIG's previous work in light of FDA's expanded authority.