FDA Guidances Being Issued Slower than Expected

We found an interesting Regulatory Focus story on the lack of FDA guidance documents since the start of President Trump’s tenure in office. FDA announced it intended to release more than 100 draft guidances in 2017 but has not been close to that amount. Recent guidances, to illustrate, can be found at the following link. Unclear reason Regulatory Focus speculates it could possibly be related to President Trump’s Executive Order aiming to reduce regulatory activity. Or, before Commissioner Gottlieb was confirmed, it may have been the lack of a top official at the agency. The answer from the administration is particularly interesting. Regulatory Focus wrote: “The answers remain unclear. FDA referred Focus questions on the matter to the White House, which referred Focus to the Department of Health and Human Services and the Office of Management and Budget, which did not respond to questions.” Some industries are patiently waiting for more FDA guidances, for example, on the Food Safety Modernization Act. However, we have seen guidances issued in several areas released in the month of August: Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry - Draft Guidance - 08/18/17 Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products - Final Guidance - 08/08/17 CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports - Draft Guidance -08/08/17 Child-Resistant P...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs