FDA
North America
April 27, 2022
Drug Products, Including Biological Products, that Contain Nanomaterials
Guidance for Industry April 21, 2022 Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products.3 Nanotechnology...
ANDA
FDA
April 27, 2022
Providing Submissions in Electronic Format — Postmarketing Safety Reports
GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...
FDA
North America
April 26, 2022
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children
April 25, 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at...