FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Innovative Compounding Pharmacy Folsom, CA (6/20). FDA investigators conducted a 4/2015 inspection after receiving an adverse event reportedly experienced by a patient who received a domperidone product that was prepared by the firm. During the inspection, the investigators noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products you were producing. They noted that domperidone is not the subject of a recognized monograph. Additionally, the inspection observed serious deficiencies in its practices for producing sterile drug products.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm527402.htm

Valeant Pharmaceuticals Bridgewater, NJ (11/3). FDA inspected the firm’s Rochester, NY manufacturing facility in August and documented quality system violations. The agency says the firm failed to establish and maintain procedures for validating the device design, and failed to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving design changes before their implementation.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm528043.htm

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome