Drugs

CGMP Deviations Found at MD Pharmaceutical Supply

A 4/25-5/9/22 FDA inspection at MD Pharmaceutical Supply, in Hanover, PA, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A just-released 11/22/22 Warning Letter says specific deviations were:

failing to adequately investigate and document complaints or any unexplained discrepancies with the original API manufacturer;
failing to perform holding of API under appropriate CGMP to avoid loss of API identity or purity; and
failing to perform repackaging and relabeling of API under appropriate CGMP to avoid mix-ups with potential cross-contamination.

FDA recommends that MD engage a qualified consultant to evaluate its operations and assist in meeting CGMP requirements. The letter acknowledges the company’s commitment to cease repackaging and relabeling of drugs at the Hanover facility. If MD intends to resume operations, FDA says it is to be notified before operations resume.

The company was told to respond with a list of specific actions it has taken to address any 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