Sec. 100.1 What is the purpose of these regulations? 100.2 What definitions apply to these regulations? 100.3 What programs and activities of the Department are subject to these regulations? 100.4 [Reserved] 100.5 What is the Secretary’s obligation with respect to Federal interagency coordination? 100.6 What procedures apply to the selection of programs and activities under these regulations? 1...

The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the ...

Unrelieved pain from cancer and HIV/AIDS is a substantial worldwide public-health problem. Inadequate pain relief is partly due to excessively strict national drug-control policies that constrain medical use of essential medicines such as morphine. Romania's drug-control policies are more than 35 years old and impose an antiquated regulatory system that is based on inpatient post-surgical manag...