世界の薬事規制動向＆情報を配信

US FDA's COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

By nielsen-hobbs 29 Nov 2020

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Topic Coronavirus FDA

Medtech Insight: 世界の医療機器・医療技術の最新情報

Guidance FDA Will Look Other Way If Manufacturers Modify Imaging Systems To Fight COVID19

27 Nov 2020

The US agency has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images, as US health care workers fight the novel coronavirus.

Topic Coronavirus FDA

世界の薬事規制動向＆情報を配信

For Coronavirus US FDA Is At The Podium But Not On The Task Force

27 Nov 2020

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic FDA Vaccines Infectious Diseases Coronavirus

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic

27 Nov 2020

FDA guidance updated in mid-April offered workarounds for trial sponsors attempting to conduct clinical studies in a time of travel limitations, staffing changes and heightened patient safety issues. For trials involving complex products and administration, such as cell and gene therapies, sponsors must determine whether modified protocols can still maintain trial integrity. If not, it may be time to press pause. 

Topic Coronavirus FDA

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Boosts Development Of OTC COVID-19 Tests With New Template

By elizabeth-orr 27 Nov 2020

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Topic Coronavirus FDA Diagnostics

世界の薬事規制動向＆情報を配信

Webinar: FDA and its Commissioners

By nielsen-hobbs 27 Nov 2020

The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?

Topic FDA