Category: Drugs

Cooley Alert: Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law

Biologic drug makers will soon have to alert the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement is part of the Patient Right to Know Drug Prices Act, which President Trump signed into […]

FDA Releases Draft Guidance Regarding Indications and Usage Section of Drug Labeling

The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]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