Phase 1 IND Procedures and Policies
Find FDA procedures and policies related to Phase 1 IND submissions
Drug approvals, label changes, and FDA drug news.
Find FDA procedures and policies related to Phase 1 IND submissions
Information on FDA's CMC regulatory flexibilities for Phase 1 INDs
Find FDA learning resources related to Phase 1 IND submissions
Master Protocols for Drug and Biological Product Development
Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.
Information on patents and suitability petitions that impact the availability of generic drugs.
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
La dentición es una fase normal de la infancia que no necesita “curarse” con medicamentos recetados o de venta libre. La FDA advierte a los padres que los productos que contienen benzocaína no son seguros para tratar la dentición en los niños. Hay alternativas no tóxicas más seguras.
Recently FDA leadership held a roundtable discussion with 15 dedicated rare disease leaders. Hearing directly from patients and family members who navigate these incredibly challenging conditions every day was both grounding and motivating.
Efficacy supplement (new or revised indication). solution, subcutaneous. Sponsor: Zealand Pharma
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older.
The Swiss robotic surgery company, which is rolling out its Dexter system in the U.S., said the new indications will help ASCs maximize use of the system.
Find out how CDER works with partners and consortia to identify science gaps in drug development
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.
The shortage follows Hologic removing certain breast biopsy needles from the market in January.
Online Advisory Letters
Antibacterial Susceptibility Test Interpretive Criteria
About Tebipenem Pivoxil
Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.
FDA approves first oral carbapenem therapy for complicated urinary tract infections
The goal of the iPLEDGE REMS is to mitigate the risk of embryo-fetal toxicity.
International Council on Harmonisation - Safety