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 […]

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]

Docket Number: FDA-2000-D-0277 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the development […]

Docket Number: FDA-2016-D-0236 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist applicants of new drug […]

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of new drug applications (NDAs) with the development […]

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical development of drugs […]

The list of DMFs, which is updated quarterly, contains DMFs RECEIVED by March 31, 2024, for which acknowledgment letters were sent before April 10, 2024. The […]

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]