Drugs

FDA Sees Rise in GMP Violations at Supplement Makers

FDA inspections of dietary supplement makers in 2016 saw an uptick in GMP violations, according to a report by ConsumerLab.com. Last year, the agency inspected 583 dietary supplement manufacturing facilities, with 362 (62%) receiving a Form 483 indicating GMP noncompliance. In comparison, 2015 saw a GMP violation rate of 58%, and 2014 and 2013 recorded a 62% and 65% violation rate, respectively, according to the report.

The report also noted that the median number of infractions at facilities rose to four in 2016, which is double the two infractions documented in 2015. It notes that the most common infractions, each observed at more than 10% of noncompliant facilities, were:

not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement
not establishing or following written procedures for quality control
not conducting at least one appropriate test or examination to verify the identity of a dietary ingredient and/or
not preparing or following a written master manufacturing record for each batch
not producing records which included the complete information relating to the production and control of each batch

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