FDA

FDA Roundup: September 23, 2022

September 23, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices:…

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

Today, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including…

FDA Roundup: September 20, 2022

September 20, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA alerted medical device users…

FDA Committed to Strengthening U.S. Infant Formula Supply; Review Provides Roadmap to Support Ongoing Efforts

For the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S….

FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula Supply

In May 2022, FDA Commissioner Robert M. Califf, M.D., asked that I conduct an internal agency review of the agency’s actions related to multiple reports…

FDA Roundup: September 16, 2022

September 16, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, the FDA announced that it…

FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases…

FDA Roundup: September 13, 2022

September 13, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA reissued the Aug….

FDA Roundup: September 9, 2022

September 9, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:   Today, the FDA posted FAQs on…

FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

Today, the U.S. Food and Drug Administration issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas…