Drugs

PET Drug CGMP Issues at Petnet

A 3/19-4/5 FDA inspection at Petnet Solutions, Woburn, MA, found significant violations of current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drugs. A 10/17 Warning Letter says specific violations were:

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
the firm’s laboratory failed to develop and follow adequate written procedures for testing components, in-process materials, and finished PET drug products to ensure conformance with appropriate standards, including established standards of identity, strength, quality, and purity.

In the letter, FDA recommends that Petnet engage a qualified consultant to assist it in meeting CGMP requirements. The agency also notes that there are Petnet facilities throughout the U.S. that share corporate quality oversight and procedures, and says the company should comprehensively assess its global manufacturing operations to ensure that systems, processes, and the products manufactured conform to CGMP requirements for PET drug products.

Petnet was told to correct the violations promptly; respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion; and to schedule a regulatory meeting with FDA officials.

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