US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

• Source: Shutterstock

Codeine’s status as an OTC drug under US federal regulations continues as an item on the Food and Drug Administration’s latest annual list of planned OTC monograph activities it intends to initiate over the next three years.

The list published on 30 September, the fourth for the program, likely will be the final annual nonbinding forecast under...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Cloudy Tariff Conditions Expected To Linger In US

 

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 

ECHA has added two silicone ingredients used in cosmetics and personal care products to the REACH Candidate List as they are persistent and have bioaccumulative properties, requiring companies to notify customers and update safety data sheets if concentrations exceed 0.1%.

MoCRA Implementation Delay Creates More Legal Exposure For Stakeholders – Attorney

 

The delay in implementation of MoCRA is seen by many companies as a temporary reprieve, but it does create more legal uncertainty, says attorney Marissa Alkhazov of law firm Buchalter.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By 

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from Policy & Regulation