Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy
February 2, 2023
FDA Approves Trodelvy ( sacituzumab govitecan-hziy) for patients with specific metastatic hormone recepter breast cancers having received endocrine-based therapy and at least two additional therapies.
February 3, 2023
FDA Industry News:
From Our Perspective – CDER’s Continued Efforts to Widen Naloxone Access
By: Marta Sokolowska, Ph.D., CDER Deputy Center Director for Substance Use and Behavioral Health
The overdose crisis is one of the most devastating public health crises affecting our country. To address this evolving crisis, FDA announced our Overdose Prevention Framework – our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths – in August 2022. Under the Framework, one of our four priorities is encouraging harm reduction, which includes our efforts to expand access to lifesaving overdose reversal products such as naloxone.
While FDA has prioritized availability of naloxone products for years, we significantly ramped up our efforts to increase naloxone availability as we worked to implement the Framework.