Drugs

PET Drug CGMP Violations at N-Molecular

A 2/12-2/28 FDA inspection at N-Molecular (doing business as SOFIE and SOFIE Biosciences), Haverhill, MA, found significant violations of current good manufacturing practice regulations for positron emission tomography (PET) drugs. A 9/24 Warning Letter says the specific violations were:

failing to take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications;
the firm’s facilities are not adequate to ensure the prevention of contamination of equipment or product by environmental conditions that could reasonably be expected to have an adverse effect on product quality; and
failing to approve or reject proposed changes to existing processes, before they were implemented, to ensure that they maintain the identity, strength, quality, and purity of a PET drug, and failing to demonstrate that any change does not adversely affect the identity, strength, quality, or purity of the PET drug prior to being implemented.

The letter says the company is responsible for investigating the violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all its facilities. It was told to correct the violations promptly and to respond with a list of steps taken since the inspection to correct the violations 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

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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