Regulatory Affairs

FDA Extends Comment Period for Generic Safety Labeling Rule

The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More

Lawmakers Propose Bill to Ban Pay-for-Delay Deals

U.S. lawmakers Dec. 11 introduced legislation that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More

New Compounding Laws Don’t Change FDA Position on Makena

The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More

GSK Reforms Sales Practices in Wake of China Scandal

GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More