Division of Pfizer Inc.
Latest From Hospira Inc.
US FDA warning letter instructed Pfizer to implement a global corrective and preventive action plan to address widespread data integrity problems. While the impact of the warning letter on the site is expected to be minimal due to its closure, the global impact on the company’s sterile drug operations could be significant.
A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.
Industry groups suggest that the drug shortage crisis needs to be addressed by changing the economic model for reimbursement, while US FDA can help by making it easier for manufacturers to use “standby” facilities as needed to bridge supply gaps and by providing generic drug manufacturers with more notice on when applications will be approved.
- Diagnostic Imaging Equipment & Supplies
- Infusion Therapy Equipment and Supplies
- Monitoring Equipment & Devices
- Drug Delivery
- Generic Drugs
- Therapeutic Areas
- Hospital Products Division (Abbott)
- North America
- Parent & Subsidiaries
- Pfizer Inc.
- Senior Management
F. Michael Ball, CEO
Thomas E Werner, SVP, Fin. & CFO
Sumant Ramachandra, PhD, SVP, CSO
Marc Yoskowitz, SVP, Strategy & Corp. Dev.
- Contact Info
Phone: (224) 212-2000
275 N. Field Dr.
Lake Forest, IL 60045
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