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Latest posts
Last updated 2 days ago
Investigational New Drug Application (IND)
2 days ago
Get to know the investigational new drug application (IND). This includes the...
Patent Certifications and Suitability Petitions
2 days ago
Information on patents and suitability petitions that impact the availability of generic...
Commissioner's National Priority Voucher (CNPV) Pilot Program
2 days ago
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program...
¿Deben medicarse las encías de los bebés durante la dentición? No
2 days ago
La dentición es una fase normal de la infancia que no necesita...
Lessons Learned from our Roundtable with Rare Disease Advocates
3 days ago
Recently FDA leadership held a roundtable discussion with 15 dedicated rare disease...
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
3 days ago
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the...
FDA Approves First Single-Dose Generic Treatment for Influenza
3 days ago
The U.S. Food and Drug Administration today approved the first generic of...
Scientific Public Private Partnerships and Consortia
3 days ago
Find out how CDER works with partners and consortia to identify science...
Investigational New Drug (IND) Application
3 days ago
Get to know the investigational new drug application (IND). This includes the...
FDA approves first oral carbapenem therapy for complicated urinary tract infections
4 days ago
FDA approves first oral carbapenem therapy for complicated urinary tract infections
FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
4 days ago
FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary