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Mizrahi Kroub
In some cases, medical negligence during childbirth can lead to severe injuries for both the baby and the mother.
Crowell & Moring LLP
In September 2023, the Centers for Medicare & Medicaid Services released a new state total cost of care model called the States Advancing All-Payer Health Equity Approaches and Development Model.
Taft Stettinius & Hollister
On March 13, 2024, Indiana adopted Senate Bill Number 9 (Senate Bill 9), instituting state notification requirements for health care entitie...
Steptoe LLP
The US Food and Drug Administration (FDA) published a Final Rule on March 22, 2024, amending its regulation at 21 C.F.R. § 170.105 to provide additional bases upon which the agency may determine that a Food Contact Notification (FCN) is no longer effective.
Exponent
Agency recommends methods for virus detection and clearance for biotechnology manufacturers and products derived from animal or human cell lines...
Exponent
Food and Drug Administration draft guidance for metallic and calcium phosphate coatings on orthopedic devices is now open for comments...
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Bass, Berry & Sims
As of March 31, 2024, Nevada's state consumer health data law, Senate Bill No. 370 (SB 370), enters the state-level consumer health data privacy fray. Similar to Washington's...
Willkie Farr & Gallagher
On March 5, 2024, the Department of Justice ("DOJ"), the Federal Trade Commission ("FTC"), and Department of Health and Human Services ("HHS," together the "Agencies")...
Jones Day
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with several notable changes.
Mintz
Mintz's annual report on False Claims Act case activity analyzes data from the DOJ and the firm's Health Care Qui Tam Database, and explores the 2023...
Crowell & Moring LLP
Starting next week, on April 1st, health care entities in California closing "material change transactions" will be required to notify California's new Office of Health Care Affordability ..
K&L Gates
Almost one year ago, Washington State passed the "My Health, My Data" Act (the Act), which aims to protect Washington consumer health data, particularly...
Sheppard Mullin Richter & Hampton
Healthcare provider compliance programs face increasing government scrutiny by a variety of federal and state agencies.
Mintz
In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, ...
Katten Muchin Rosenman LLP
The FTC, DOJ and HHS are paying close attention to the impact of private equity investment in the health care industry.
Goodwin Procter LLP
In honor of Women's History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR....
Duane Morris LLP
Earlier this month, the Antitrust Division of the DOJ, the Department of Health and Human Services, and the Federal Trade Commission announced a joint cross-government inquiry...
Mintz
On March 13, 2024, Indiana joined the ranks of states exercising greater oversight and regulation of health care transactions. Senate Enrolled Act No. 9 (S.B. 9)...
Goodwin Procter LLP
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.
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