Drugs

Untitled Letter for India’s Nectar Lifesciences

A 3/2-3/10 FDA inspection at Nectar Lifesciences in Chandigarh, India, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released Untitled Letter says the specific violations were:

failing to establish appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes; and
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter says similar deviations were cited in a 2014 inspection and discussed in a 2016 regulatory meeting. At that time, it says, Nectar proposed specific remediation to address the inspection observations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says.

FDA recommends that if Nectar intends to manufacture drugs for the U.S. market it should engage a qualified consultant to assist it in meeting CGMP requirements.

Nectar was told to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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