6/24付の米国FDAによるCOVID-19絡みガイダンス等の発出について、筆者のお好みでお伝えします。
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l6/24付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l6/24付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 24, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-24-2020
l6/24付News Release「Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19」～食品関係です。
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-joint-statement-usda-and-fda-food-export-restrictions-pertaining-covid
l6/24付ガイダンス「Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment」
https://www.fda.gov/media/79516/download
l6/24付ガイダンス「Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment」
https://www.fda.gov/media/75149/download
［上記2点のガイダンス関連ニュース記事］
l6/24付RAPS「FDA finalizes bacterial pneumonia drug development guidances」
https://www.raps.org/news-and-articles/news-articles/2020/6/fda-finalizes-bacterial-pneumonia-drug-development
l6/24付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
l6/24付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
［米国FDAの医療機器全般に関してのニュース記事］
l6/24付RAPS「Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers」
https://www.raps.org/news-and-articles/news-articles/2020/6/regulatory-considerations-for-fda-enforcement-poli
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l6/24付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l6/24付Updated「Coronavirus (COVID-19) Update: Daily Roundup June 24, 2020」
https://www.fda.gov/news-
l6/24付News Release「Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19」～食品関係です。
https://www.fda.gov/news-
l6/24付ガイダンス「Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment」
https://www.fda.gov/media/
l6/24付ガイダンス「Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment」
https://www.fda.gov/media/
［上記2点のガイダンス関連ニュース記事］
l6/24付RAPS「FDA finalizes bacterial pneumonia drug development guidances」
https://www.raps.org/news-and-
l6/24付Updated「Emergency Use Authorizations」
https://www.fda.gov/medical-
l6/24付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
［米国FDAの医療機器全般に関してのニュース記事］
l6/24付RAPS「Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers」
https://www.raps.org/news-and-
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