the Food and Drug Administration and First Amendment Issues

A global view of the First Amendment constraints of FDA.

The First Amendment and FDA restrictions on off-label uses: the call for a new approach.

Part 73—listing of Color Additives Exempt from Certification

The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued. DATES: This rule is effective August 12, 2013. FOR FURTHER INFORMATION CONTACT: Eri...

A new history and discussion of 180-day exclusivity.

Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended the provision substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The fundamental goal behind 180-day exclusivity was to provide an incentive for generic drug applicants to challenge inn...

Content analysis of policy documents in Iran's public libraries

Purpose: The purpose of this research is to determine the categories and issues that were considered by national policymakers in the field of public libraries of the Islamic Republic of Iran. This study seeks to identify those issues and problems for which policymakers have been trying to find solutions by analyzing the content of policy documents. Method: This research is a qualitative resear...