FDA Policy/General

Latest FDA Warning Letters

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

Cassandra E. Curtis Indianapolis, IN (1/27): FDA inspected the clinical investigator 9/2016 and a Pfizer-sponsored Phase 4 study “Evaluating the Neuropsychiatric Safety and Efficacy of 12 Weeks Varenicline Tartrate [Pfizer’s Chantix] 1 mg BID and Bupropion Hydrochloride 150 mg BID for Smoking Cessation in Subjects with and Without a History of Psychiatric Disorders.” The agency cited the investigator for failing to ensure that the investigation was conducted according to its plan. FDA also cited her for failing to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm548678.htm

Sanapac Co. Dallas, PA (3/24): FDA inspected the firm’s facility 11/2016 and cited serious GMP violations involving its dietary supplement manufacturing. The agency also reviewed the firm’s Web site and determined that products are being marketed as drugs based on claims on the site.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm549784.htm

Trone Health Services dba Medicap Pharmacy Meridian, ID (3/22): FDA inspected the drug compounding pharmacy 7/2016 and cited it for serious deficiencies in its practices for producing sterile drug products. For example, the investigators noted that the firm had produced drug products intended or expected to be sterile in a non-ISO 5 powder containment hood. FDA said the drug products were produced in an environment that posed a significant contamination risk.

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm548695.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