Biologics

‘Objectionable Conditions’ in Doctor’s Clinical Trial

A 3/15-5/19/2023 FDA Bioresearch Monitoring Program inspection of a clinical study led by Konrad Rejdak in Lublin, Poland, found objectionable conditions. A just-released 5/29 Warning Letter says the agency has determined that Rejdak violated regulations governing the proper conduct of clinical studies involving investigational products. Specific violations were:

failure to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational product;
failure to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations, and failure to protect the rights, safety, and welfare of subjects; and
failure to retain records required to be maintained for two years following the date a marketing application is approved.

The letter says Rejdak should investigate and determine the causes of any violations and take prompt actions to implement corrections to prevent the recurrence of similar violations in current and future studies for which he is the study director.

FDA says his written responses to the inspection observations conflict with the information he gave during the inspection and fail to address the observations and provide any corrective action plans that have been or will be implemented to prevent such violations in the future.

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