Category: Drugs

FDA Releases Draft Guidance Regarding Indications and Usage Section of Drug Labeling

The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]

FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]

***UPDATED*** Senate ‘Right to Try’ Bill Under Consideration in the House of Representatives

***6/8/18 Update*** President Trump signed S. 204, now Public Law No: 115-173, into law on May 30th. ***5/23/18 Update*** The House passed S. 204 on Tuesday in a 250-169 vote in favor of the measure. The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right […]