Benralizumab is now approved by the US Food and Drug Administration for the treatment of asthma in children older than 6 years. Marketed as Fasenra, the […]
To promote shared learning and understanding with external stakeholders, FDA continues to oversee and support numerous demonstration (i.e., research) projects on Digital Health Technologies (DHTs) through […]
With the start of GDUFA III in FY 2023, the Generic Drugs Program monthly and quarterly activities reports were combined into one report. Also, reported metrics […]
TOPLINE: Breaking up long sitting periods with short, frequent bouts of light-intensity walks may reduce the increased levels of postprandial vascular inflammatory biomarkers seen in people […]
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
BUDAPEST — Changing the way that psychiatric care is delivered can significantly reduce the use of coercive measures, experts said at the 32nd European Congress of […]
On this page As displayed in the Federal Register notice on October 20, 2022, FDA is continuing the Complex Innovative Trial Design (CID) Paired Meeting Program, […]
Docket Number: FDA-2001-D-0137 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations for sponsors of orally inhaled and intranasal corticosteroids […]
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. This guidance was developed and issued […]
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