FDA Announces Compounding Research Projects

News
Article

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

FDA announced on Sept. 26, 2018 that it has entered into an agreement with the National Academies of Science, Engineering & Medicine (NASEM) and has expanded agreements with the University of Maryland (UMD) and Johns Hopkins University Centers for Regulatory Science and Innovation (JHU CERSIs) to conduct research on the compounding of drugs.

NASEM will examine the use of compounded bioidentical hormone replacement therapy (BHRT) products, such as progesterone and testosterone, that sometimes are used instead of FDA-approved drug products for hormone replacement therapy. NASEM will evaluate the safety and effectiveness of these products.

NASEM will also examine the safety and effectiveness of multi-ingredient compounded topical pain creams, which typically contain multiple APIs. According to FDA, some of these APIs may not be approved for topical use or for pain relief. The agency has seen adverse events, including skin reactions and death, in patients who have used these types of products.

The agency’s previous collaborations with UMD and JHU CERSIs to research the development of a list of bulk drug substances, or APIs, used in compounding have been expanded. UMD CERSI’s research will expand to 225 bulk drug substances over the next three years. JHU CERSI, which completed its exploratory research, will initiate a one-year research project to evaluate the safety and effectiveness of six bulk drug substances-inositol, methylcobalamin, glutathione, 2,3-dimercapto-1-propanesulfonic acid sodium, oxytocin, and melatonin-used to treat autism spectrum disorder.

Source: FDA

 

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes