Biologics

HCT/Ps Regulation Deviations at Reproductive Technologies

An 8/5-8/16/19 inspection at Reproductive Technologies, Berkeley, CA, found significant deviations from regulations for human cells, tissues, and cellular and tissue-based products. A just-released 11/6/19 Warning Letter says specific deviations were:

failing to quarantine semen from anonymous donors until the required retesting;
failing to test anonymous semen donors for West Nile Virus using an FDA-licensed NAT donor screening test at the time of the first donation that is recovered within the 6/1 through 10/31 testing period and/or failing to retest anonymous semen donors at least six months after the date of donation of semen;
failing to determine as ineligible donors who are identified as having a risk factor for or clinical evidence of any of the relevant communicable disease agents or diseases for which screening is required;
failing to perform a complete donor screening procedure on a donor;
failing to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, or clinical evidence of, relevant communicable disease agents and diseases; and
failing to establish and maintain procedures for all steps performed in testing, screening, determining donor eligibility, and complying with all other regulatory requirements.

Reproductive Technologies was told to take prompt steps to correct the violations and prevent their recurrence and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion of 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