Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more
On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more
On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more
The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more
In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more
Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020,...more
Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more