FDA Provides Update on Agency Response to Monkeypox Outbreak

Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked … Read more

WHO publishes new guidelines on HIV, hepatitis and STIs for key populations

Today, WHO published new Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations. The guidelines are officially launched at the AIDS 2022 Conference in Montreal, Canada, in a satellite session entitled: Launching new WHO guidelines for key populations: Focus for impact.  The guidelines outline a public health response to … Read more

FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.   “It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential … Read more

WHO calls on global community to “do one thing” to save lives on World Drowning Prevention Day

Today, the World Health Organization (WHO) issued a call for people around the world to “do one thing” to prevent drowning. As one of the leading causes of death globally for children and young people ages 1–24, and the third leading cause of injury-related deaths overall, drowning tragically claims more than 236 000 lives each … Read more

FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

The U.S. Food and Drug Administration prioritizes the health and safety of American consumers and patients as well as animals and uses a variety of tools for the appropriate oversight of FDA-regulated products and establishments. With manufacturers and supply chains dispersed around the world, the FDA works to help ensure that only products that meet … Read more

FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

Today, the U.S. Food and Drug Administration announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U.S.  “Parents and caregivers should have confidence that our collective work with federal partners, manufacturers and retailers means more infant formula that … Read more

Urgent call for better use of existing vaccines and development of new vaccines to tackle AMR

The World Health Organization today released the first-ever report on the pipeline of the vaccines currently in development to prevent infections caused by antimicrobial-resistant (AMR) bacterial pathogens. WHO’s analysis points to the need to accelerate trials for AMR related vaccines in late-stage development and maximise the use of existing vaccines. The silent pandemic of antimicrobial … Read more