Bill of Health

APRIL 7, 2023

Research centers and companies that received government funds are typically allowed to manage their contractual and licensing terms independently with their commercial partners. Shamnad Basheer, a stalwart Indian IP lawyer, proposed in 2012 an ‘investment protection regime’ for innovation that fits well in the mRNA context.

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COVID-19 Vaccine COVID-19 Governance Public Health 147

HIT Consultant

JULY 11, 2024

Health Sector Cybersecurity Coordination Center and the Office of Information Security, the frequency of healthcare data breaches has trended upward since 2012. Food and Drug Administration (FDA). According to a report from the U.S. Research — and real-world events — demonstrate implantable pacemakers are vulnerable to cyberattacks.

FDA 115

FDA Hospitals Governance Ransomware 115

Hall Render

AUGUST 10, 2023

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

Bill of Health

JUNE 1, 2023

Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban. By Doron Dorfman On May 11, the U.S. Despite this nuance, the new policy categorically excludes PrEP users.

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Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief.

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 2012); Amarin Pharma, Inc. FDA , 119 F. Caronia , 703 F.3d

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

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FDA Licensing Doctors Governance 59