Monograph Reform

Browse Monograph Reform Content

FDA headquarters sign in Washington DC

The Annual Forecast for Planned Monograph Activities describes planned monograph activities that FDA intends to address over the ensuing three years.

FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.

Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.

This proposed Safety Administrative Order (AO) is only for the single ingredient propylhexedrine.

The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.

Learn about CHPA's current slate of federal legislative priorities including OTC regulatory reform, dietary supplement regulation modernization, supply chain and product integrity, and more.

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

Filter Results