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CDER

 •  January 11

Contact PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may...

CDER

 •  January 3

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles. Risk Statement:...

CDER

 •  January 3

As part of FDA’s work to prevent and mitigate drug shortages, the Agency has created the FDA Drug Shortage Assistance Award to provide public recognition to drug companies and manufacturers who have demonstrated a commitment to preventing or alleviating drug shortages of medically necessary drugs. This award recognizes efforts of drug companies and...

CDER

 •  December 22, 2017

AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem...

CDER

 •  December 21, 2017

On January 01, 2018, the International Council for Harmonisation (ICH) Q3D Elemental Impurities guidance, and United States Pharmacopeia (USP) General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures will reach their official implementation date for new and existing human drug products marketed in the United...

CDER

 •  December 19, 2017

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to...

CDER

 •  December 19, 2017

PDUFA IV Information Technology Plan Abbreviated Update (PDF - 591 KB) (5/2010)

CDER

 •  December 11, 2017

There are six general types of 3D printers. This semisolid extrusion 3D printer in CDER’s Office of Testing and Research is small, inexpensive and flexible, and preferred in personalized health care settings. Ahmed Zidan, Ph.D., Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug...

CDER

 •  December 6, 2017

The FDA is announcing three public meetings entitled “Enhanced Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA).” These public meetings are intended to provide members of the drug distribution supply chain and other interested stakeholders an opportunity to discuss strategies and issues related to the enhanced drug...

CDER

 •  November 16, 2017

Janet Woodcock, M.D.—Director, Center for Drug Evaluation and Research (CDER) Real-world evidence is information on patient’s health and health care that comes from multiple sources within and outside the clinical setting. Examples include electronic health records, claims and billing data from health plans, medical product or disease registries,...