Medmarc Blog (blog.medmarc.com)
Regulatory and Compliance (8)
FDA Sets 50% Efficacy Benchmark in Vaccine Guidance
The FDA has released a guidance for development of vaccines in response to the COVID-19 pandemic, which among other things suggests the agency will push harder to ensure that any such studies...
The PREP Act and the Revocation of an Emergency Use Authorization
In recent weeks, the FDA has revoked Emergency Use Authorizations (EUAs) for several products meant to combat COVID-19. These include the June 15, 2020 revocation [fda.gov] (download 1) of the...
FDA Moves on Home Sample Collection for COVID-19
The FDA has broken new ground on numerous occasions as a result of the COVID-19 pandemic, including with the release of a voluntary template for at-home sample collection kits under the emergency...
FDA Issues Pandemic Policy for Supplements
The FDA and other agencies at the U.S. Dept. of Health and Human Services have taken a number of measures to push back against the COVID-19 pandemic, but an agency at the Dept. of Commerce is...
PTO Eyes Prioritized Patents to Combat Covid-19
The FDA and other agencies at the U.S. Dept. of Health and Human Services have taken a number of measures to push back against the COVID-19 pandemic, but an agency at the Dept. of Commerce is...
ONC, CMS Delay Compliance Dates for EHR Interoperability
The COVID-19 pandemic has incurred a number of regulatory casualties in recent weeks, and the final rules for electronic health records (EHRs) promulgated earlier this year are two of the...
EMA Proposes Delay of MDR Implementation
As the world grapples with the newest version of the coronavirus, regulatory agencies across the globe are reacting with a number of moves, mostly to relax existing regulatory requirements. In...
FDA Inks Combo Product Feedback Guidance
The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts. The draft deals with...