miércoles, 31 de octubre de 2018

FDA approves new flu treatment | Medical device cybersecurity | Dried plasma guidance


U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

FDA approves new drug to treat influenza
Yearly vaccination still the best way to prevent and control flu outbreaks

CDC recommends: Get your flu shot by October 31

On October 24, 2018, FDA approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.

Flu season is already well underway. The U.S. Centers for Disease Control and Prevention (CDC) recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. 

FDA proposes updated cybersecurity recommendations
To help ensure device manufacturers are adequately addressing evolving cybersecurity threats
On October 17, 2018, FDA issued a draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (PDF, 604 KB), which provides updated recommendations to industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk.

FDA will host a public workshop January 29-30, 2019 to discuss this guidance.

Information for industry
  • FDA has published a table of surrogate endpoints that were the basis of drug approval or licensure. This table, which is available as a downloadable spreadsheet, provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs. This table also fulfills a 21st Century Cures Act requirement to publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product” under both accelerated and traditional approval pathways. Comment by December 31, 2018. (October 30, 2018)
More: MCM-Related Guidance by Date
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