The Business Market Assessment tool to helps you understand the initial investment and recurring regulatory compliance costs you’ll face. The guide walks you through the revenue vs cost modeling calculations to help you judge the market viability of your product and see if a specific market makes sense.
Category Archives: Advocacy and Regulations
Arizona’s Launch of the NAM Pharma Manufacturing Report
Learn about the biopharmaceutical industry’s footprint in the state of Arizona as we discuss the National Association of Manufacturers’ report:
Ensuring a Health Future: The Impact and Importance of Pharmaceutical Manufacturing.
Speakers:
Shawn DuBravac, PhD, CFA, President, Aviro Institute and New York Times Best Selling Author
Garrick Taylor, EVP, Arizona Chamber of Commerce & Industry
Moderator: Joan Koerber-Walker, president & CEO, Arizona Bioindustry Association (AZBio)
Arizona Expands Telehealth Law, Making it Broadest in the Nation
On May 5, 2021, Governor Ducey signed H.B. 2454, legislation which dramatically expands access to telehealth services in Arizona. The legislation—the most expansive in the country—makes telemedicine a permanent fixture of Arizona’s healthcare system.Continue reading
Clouds Over the Capitol
TRIPS Waiver, MCIT, HR3. If you are not familiar with these policy developments, you probably should be.
The United States medtech and biotech industries make a tremendous impact on people’s lives. When policy makers and Federal Agencies work together, the impact is made even greater. However, some policy decisions can have the opposite effect.
Governor Ducey’s Budget Focuses On Education, Tax Relief
News Release: January 15, 2021
Budget Also Invests In Public Health, Public Safety, Infrastructure And Wildfire PreventionContinue reading
CMS Releases Final Rule on Medicare Coverage of Innovative Technology (MCIT)
The CMS rule the establishes a new coverage pathway – MCIT – for breakthrough medical technologies.
BIO Leads Group Challenging Administration’s “Most Favored Nation” Rule
On December 4, 2020, the Biotechnology Innovation Organization (BIO), the California Life Sciences Association (CLSA), and BIOCOM California today filed a challenge against the Department of Health and Human Services’ (HHS) attempt, during the final days of the Trump Administration, to implement for the first time ever a “Most Favored Nation” reimbursement policy for certain drugs administered by Medicare Part B providers – drastically altering this system in ways that will harm their ability to serve America’s most vulnerable senior citizens.Continue reading
What Comes Next as Election Week Draws to a Close
The 2020 Election Cycle has been historic and unique in many ways. As the sun rises on the 6th day after Election Day, here are some updates and resources to help you stay in the loop on what comes next.Continue reading
BIO’s Dr. Michelle McMurry-Heath Congratulates President-Elect Biden & Other Newly Elected Leaders of Both Parties Who Won
Statement from Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO)Continue reading
AdvaMed Issues MedTech Compliance Guidance For COVID-19 Response
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today announced availability of a newly created “Code of Ethics Compliance Guidance Related to the COVID-19 Response.”
“This guidance seeks to help AdvaMed members and other medical technology companies develop and implement processes that both support rapid decision-making in the context of the pandemic and mitigate any related compliance risks,” said Christopher L. White, AdvaMed COVID action team leader, chief operating officer and general counsel.Continue reading