Drugs

CDER’s Cavazzoni Adds Deputy for Substance Abuse

CDER director Patrizia Cavazzoni has appointed associate director for controlled substances Marta Sokolowska to serve as deputy Center director for substance use and behavioral health, a new position in the Center. In this new role, she will continue to oversee the Controlled Substances Program at the agency.

“At a time of the growing drug overdose crisis in the U.S., Marta will be the Center’s executive-level leader responsible for strengthening and advancing our public health response to the non-medical use of substances with abuse potential,” Cavazzoni says. “These efforts include minimizing risks associated with problematic use, while enabling appropriate access for medical use.”

Sokolowska will advise senior agency officials on “shaping scientific and policy interventions and executing strategies pertaining to the use of controlled substances and behavioral health programs,” according to Cavazzoni. “She will represent FDA at various government leadership forums focused on addressing behavioral health issues related to substance use, addiction, and overdose. Marta will also provide input on proposed legislation and drug regulations.”

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