Drugs

Inspection Finds CGMP Deviations at Huron Pharmaceuticals

A 12/13-22/16 FDA inspection at Huron Pharmaceuticals, Farmington Hills, MI, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 4/20 Warning Letter from the agency’s Detroit District Office. Specific deviations included:

failing to transfer all quality or regulatory information received from the API manufacturer to customers;
failing to establish, document, and implement an effective system for managing quality; and
failing to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.

“Based on the nature of the deviations we identified at your firm,” the letter says, “we strongly recommend engaging a consultant qualified to evaluate your operations and assist your firm in meeting CGMP requirements.”

Huron was told to correct the deviations promptly and to respond with a list of steps the firm has taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.

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

Read more

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