Bill of Health
APRIL 21, 2023
FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. Eroding Judicial Deference to the FDA – Consequences for Public Health. JAMA Health Forum. J Health Polit Policy Law. N Engl J Med.
Bill of Health
APRIL 7, 2023
Together, these articles underscore the injustice of the present moment and emphasize the need to reform intellectual property protections for government-funded inventions of public health significance. Recent Research on Public Funding of mRNA Technology The first of the two new articles is an in-depth empirical study of U.S.
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Healthcare It News
DECEMBER 30, 2022
One example is partnering with Healthy Together, which uses the agency's API to provide veterans with secure mobile access to their health records. FDA authorizes at-home COVID-19 tests from Amazon, Roche, Siemens. And it will help public health officials improve public health policy and lower overall costs.
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. This fits a paradigm I describe in recent work , the demedicalization of preventive health care.
SQA
AUGUST 2, 2021
Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. b) and 320.31(d)(3)).
Kaiser Health News
JANUARY 12, 2023
On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.
Drug & Device Law
MAY 11, 2023
A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.
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