Drugs

Northwestern University Clinical Investigator Cited

An FDA inspection at the Northwestern University School of Medicine between 6/17/16 and 7/11/16 found that Division of Immunotherapy chief Richard Burt violated regulations governing the proper conduct of clinical studies involving investigational new drugs. Specific violations included:

failing to fulfill the general responsibilities of sponsors and to ensure that investigations are conducted in accordance with the general investigational plan and protocols contained in the IND;
failing to submit a protocol amendment to FDA when there was a significant change in protocol design, and failing to submit a protocol amendment when new investigators were added to carry out a previously submitted protocol within 30 days of the investigators being added;
failing to select investigators qualified by training and experience as appropriate experts to investigate the drug;
failing to obtain certain required information from investigators prior to permitting their participation in the clinical investigation, including a signed investigator statement, curriculum vitae, and financial disclosure information;
failing to give each participating investigator an investigator brochure containing the information described in regulations;
failing to monitor the progress of clinical investigations being conducted under Burt’s IND;
failing to make adequate annual reports to FDA; and
failing to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and the applicable regulations, and to protect the rights, safety, and welfare of subjects under Burt’s care.

Burt was told the respond with written documentation of additional actions he has taken or will take to correct the violations and to prevent the recurrence of similar violations in current and future studies for which he is the sponsor and/or clinical investigator.

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