Biologics

HCT/P Violations at Ponya Therapeutics

A 6/2-6/6 FDA inspection at Lux Therapeutics, doing business as Ponya Therapeutics, in Brookhaven, GA, documented significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P). An 11/25 Warning Letter says the specific violations were:

failure to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspection and tests, with the validation activities and results documented, including the date and signature of the person approving the validation; and
failure to provide a summary of records to accompany an HCT/P that contains a listing and interpretation of the results of all communicable disease tests performed.

The letter says the firm’s responses to the inspection observations were inadequate.

Ponya was told to promptly correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and 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

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