Drugs

Bob Temple Gets New Title, Role Remains the Same

CDER director Patrizia Cavazzoni has removed Bob Temple’s deputy Center director title and renamed him senior advisor for clinical science within her immediate office. Temple’s previous deputy position no longer exists in Cavazzoni’s current office structure. Asked whether the new title represents a significant change in his leadership position, Temple told FDA Webview that there is “no real change” in his role.

“In this role, Bob will serve as the Center executive-level leader on the clinical evaluation of drugs and related scientific and policy matters,” a CDER spokesman told us. “He will provide advice and counsel to the Center director and higher-level agency officials; leadership in the advancement of policies and guidances related to the clinical evaluation of drugs; and advance understanding of FDA’s responsibilities for enforcing standards and regulations.”

Temple also continues in his ongoing dual role as senior advisor to the Office of New Drugs (OND) director, providing advice on policy, guidance and difficult problems in drug development and their regulation. “Bob will also advise on overall activities, policies, and procedures involving interpretation and adaptation of Center and agency programs and policy objectives and will provide counsel to the director on a variety of policy decisions having a major impact on the conduct, coordination, and inter-relationships of drug review programs,” the spokesman said.

Joining FDA in 1972, Temple has been at his office-level clinical science position since 2012.

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