Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection,…

Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations

Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations

Benefits of Emerging Technology Program (ETP)

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product…

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…