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Foley Hoag LLP
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate.
Arnold & Porter
In an effort to limit challenges for patient access, patient adherence to recommended treatment, or adoption of innovative products and services, providers, suppliers, and product manufacturers seek ways to address such roadblocks.
Arnold & Porter
11. COVID-19 and Life Sciences, the US government has used a wide variety of public procurement and funding strategies for needed medical countermeasures during the pandemic.
Arnold & Porter
The Department of Justice (DOJ) is breathing new life into False Claims Act (FCA) enforcement based on the Stark Law (Stark), 42 U.S.C. § 1395nn, also known as the Physician Self-Referral Law.
The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).
In episode 25, Halle and Michael discuss the process of building a board for a startup. They cover topics such as the importance of board structure, when to formalize the board...
Nixon Gwilt
How the federal government and the states are regulating AI tools and functions in digital health today...
Foley & Lardner
Antibody Drug Conjugates (ADCs) represent an innovative class of potent anti-cancer compounds. ADCs are widely used in the treatment of hematologic malignancies and solid tumors.
Greenberg Traurig, LLP
On April 1, 2024, the U.S. Food and Drug Administration (FDA) issued a statement reminding stakeholders, especially animal drug manufacturers and veterinarians...
Crowell & Moring LLP
In this episode, hosts Payal Nanavati and Savanna Williams talk to Paul Pollock and Wayne Pryor about how private equity (PE) got its start in the health care industry, current trends in PE regulation, and where listeners can expect to see PE to continue investing in the industry.
Pierson Ferdinand
Washington's My Health My Data Act (MHMDA), signed into law last year, is now in effect. MHMDA's intent was to address consumer health-related data not otherwise...
Crowell & Moring LLP
The Office of the National Coordinator for Health Information Technology released a draft of their 2024–2030 Federal Health IT Strategic Plan on March 27, 2024, updating the 2020-2025 Federal Health IT Strategic Plan.
Michael Best & Friedrich
This week, USDA confirmed an outbreak of highly pathogenic avian influenza (HPAI) in dairy herds in Texas, Kansas and New Mexico, afflicting primarily older dairy cows causing decreased lactation...
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates...
Holland & Knight
The U.S. Food and Drug Administration (FDA) has increased regulatory activity with regard to per- and polyfluoroalkyl substances (PFAS).
In this episode, Dr. Alicia Jackson, co-founder and CEO of Evernow, discusses the importance of women's health research and the need for improved menopause care.
You only get to incorporate once, and you want to get it right. In this episode, co-hosts Halle Tecco and Michael Esquivel dive deep into the process of incorporation for startups.
In this episode, cancer survivor Kaitlin Christine, the CEO and founder of Gabbi, shares her vision to make all late stage breast cancer obsolete...
In episode 24, Halle and Michael discuss the process of raising a seed round. They cover topics such as when to raise a seed round, building relationships with investors...
Goodwin Procter LLP
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape.
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