Drugs

Republicans Threaten Subpoena on FDA Research

House Energy and Commerce Committee Republicans are threatening FDA with a subpoena if it continues to delay submitting documents on what they consider “risky” research conducted at agency facilities. The committee has called for increased scrutiny of federal laboratory biosafety protocols following the Biden administration’s lack of transparency in declassifying information related to the origins of Covid-19.

In an 11/9 letter to FDA commissioner Robert Califf, the committee leadership asks for the following:

All coronavirus research studies referenced in a 1/31 email.
All studies that have undergone Institutional Biosafety Committee (IBC) review and all documents related to the IBC reviews.
All studies that have undergone Dual Use Research of Concern (DURC) review and all documents related to the DURC reviews.
All policies and procedures related to the IBC and DURC processes.
All documents related to all extramural research that have gone through the FDA IBC and/or DURC review since September 1, 2015.

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