Medmarc Blog (blog.medmarc.com)
Churn at Justice as Drug Pricing Rule Falters Again
Bipartisan supporters of drug pricing transparency in the U.S. absorbed another blow when an appeals court rejected the Trump administration’s drug price transparency rule as lacking statutory...
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...
FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA
The Trump administration’s budget proposal for fiscal 2021 in large part reflected the administration’s past proposals for various agencies at the Department of Health and Human Services. While...