The U.S. Food and Drug Administration (FDA) has released a summary of recent news from the agency.
One of the highlights is the publication of an article by Kerry Jo Lee, M.D., Associate Director for Rare Diseases at the FDA, on the Accelerating Rare disease Cures (ARC) Program. The ARC Program aims to increase the number of treatments available for rare diseases by promoting innovative scientific design, improving regulatory policies, and engaging with patients and advocates.
Another important announcement is the implementation of Guidance for Industry (GFI) #263, which has resulted in all affected animal drug sponsors opting to change the marketing status of certain antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx). This change is intended to support the judicious use of antimicrobials in animals and ensure that animal owners consult with a licensed veterinarian for appropriate treatment.
The FDA has also authorized the marketing of Futura Medical Developments Limited’s Eroxon (MED3000), a non-medicated hydro-alcoholic gel for the treatment of erectile dysfunction in adult males aged 22 and over. This is the first over-the-counter gel intended to treat this condition.
The FDA has recently hosted its fourth Online Controlled Substances Summit, focusing on reducing the availability of controlled substances online. The illegal sale of opioids and other controlled substances through unsafe websites and social media platforms poses significant challenges for regulators, law enforcement, and others working to protect the public.
On June 15, the FDA Oncology Center of Excellence will host a public panel discussion as part of National Black Family Cancer Awareness Week. This event aims to increase cancer awareness, equity, and prevention in vulnerable populations.
Overall, these updates reflect the FDA’s ongoing efforts to advance public health, promote innovation in drug development, and address challenges related to rare diseases, antimicrobial use, erectile dysfunction treatment, controlled substance availability, and cancer awareness.
