New Guidance Aims to Protect Children Who Participate in Clinical Trials
U.S. Food and Drug Administration
The draft guidance is intended to assist industry, sponsors, and institutional review boards
Articles by U.S. Food and Drug Administration
Public-Private Partnership for Rare Neurodegenerative Diseases
U.S. Food and Drug Administration
The FDA and NIH launch a partnership aimed at understanding and combating rare neurodegenerative diseases
FDA Removes N95 Respirators from Medical Device Shortage List
U.S. Food and Drug Administration
Agency continues to monitor supply chain to help ensure continued access
FDA Releases Action Plan for Rare Neurodegenerative Diseases
U.S. Food and Drug Administration
Five-year plan fulfills a requirement of the Accelerating Access to Critical Therapies for ALS Act
Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose Expanded
U.S. Food and Drug Administration
The FDA expanded the eligibility for the vaccine booster dose to individuals five through 11 years of age
FDA Approves First COVID-19 Treatment for Young Children
U.S. Food and Drug Administration
U.S. FDA expanded the approval of the COVID-19 treatment Veklury to include pediatric patients 28 days of age
FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
U.S. Food and Drug Administration
New test provides results in less than three minutes
Meeting on COVID-19 Vaccines to Discuss Future Boosters
U.S. Food and Drug Administration
FDA announces a virtual meeting of its Vaccines and Related Biological Products Advisory Committee
FDA Urges Companies to Be “Recall Ready” to Protect Public Health
U.S. Food and Drug Administration
New guidance to help companies prepare to quickly and effectively remove violative products from the market
Authorization of COVID-19 Vaccine for Children under Five Postponed
U.S. Food and Drug Administration
FDA postpones authorization meeting of Pfizer-BioNTech COVID-19 vaccine for children six months through four years old