Baker McKenzie updates

FDA's new guidance on emergency use authorisations for COVID-19 vaccines
Baker McKenzie
  • Healthcare & Life Sciences
  • USA
  • 18 November 2020

The Food and Drug Administration (FDA) recently approved the antiviral drug Veklury (remdesivir) for hospitalised COVID-19 patients, making it the first drug to receive approval for the treatment of COVID-19. Before approving this drug, the FDA issued an emergency use authorisation for the use of Veklury in COVID-19 treatment.

Telehealth privacy issues due to COVID-19
Baker McKenzie
  • Healthcare & Life Sciences
  • USA
  • 23 September 2020

The COVID-19 pandemic has led to a significant expansion in the need for telehealth, with as many patient visits as possible being conducted using telehealth platforms. As a result, healthcare providers must meet patient needs while at the same time meeting data protection regulatory requirements under the Health Insurance Portability and Accountability Act. This video discusses the recent changes to the telehealth sector and what healthcare providers need to do to ensure that they comply with data regulations.

FDA issues draft guidance on clinical research of cannabis and cannabis-related products
Baker McKenzie
  • Healthcare & Life Sciences
  • USA
  • 05 August 2020

The US Food and Drug Administration recently issued its draft guidance on clinical research for the development of drugs that contain cannabis or cannabis-derived compounds of botanical origin (as opposed to synthetic). The guidance provides some clarity on the use of cannabis in clinical research in light of the changes made by the Agriculture Improvement Act 2018, which federally legalised hemp and derivatives that contain no more than 0.3% by dry weight of THC.

Compliance with medical product shortage reporting requirements during COVID-19 pandemic
Baker McKenzie
  • Healthcare & Life Sciences
  • USA
  • 17 June 2020

The consequences of supply chain interruptions from a compliance perspective vary slightly, depending on the type of product and its indication. Human drug products and medical device products have different requirements for reporting supply chain disruptions and the impact of COVID-19 has cast a bright light on this inequity. Compliance with reporting requirements is therefore paramount during the ongoing pandemic.

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