Transcript: Emerging Technology Program
FDA’s Emerging Technology Program is intended to encourage technology for use in product design and pharmaceutical manufacturing
Advancing Product Quality
FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.
Advancing Product Quality for Human Drugs
FDA is engaged in efforts to encourage innovations in manufacturing processes and technology and to foster a quality management system.
Drug Shortages | Additional News and Information
Drug Shortages: Additional News and Information
Advances in FDA’s Drug Safety Programs
Drug Safety is a Key Priority at the Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee Roster
ODAC roster, a lists the current members and the current number of vacancies for the committee
FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines
[09-15-2015] The U.S. Food and Drug Administration (FDA) is making changes to the requirements for monitoring, prescribing, dispensing, and receiving…
Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination
02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash…
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments…
Frequently Asked Questions | Clozapine REMS Modification
The Clozapine REMS is a shared system REMS for all approved clozapine products.