FDA Withdraws 9 Proposed FDA Regulations and Rules

As part of the Trump administration’s deregulatory push, the FDA has withdrawn nine regulations proposed for the pharmaceutical industry, some in the works for years.

They include revisions to GMPs for raw ingredients and finished products, changes in annual IND reporting, and requirements for new, clearer labeling for patients in medication guides.

The FDA proposed regulation amending GMPs for components used in manufacturing finished pharmaceuticals, first proposed in 2011, was described as a major, economically significant regulation, and likely to have effects on international trade.