Bill of Health

APRIL 24, 2023

Dmitry’s talk, “Evergreening: The FDA’s Role in the Creation of Balanced Rights for Pharmaceutical Improvements,” was developed into an article and published in the Iowa Law Review in 2019 titled “The More Things Change: Improvement Patents, Drug Modifications, and the FDA.”

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Public Health FDA Bioethics Governance 313

Bill of Health

NOVEMBER 30, 2022

This post is an adaptation of an article published in the Harvard Social Impact Review. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. The FDA first approved mifepristone, in a regimen with misoprostol, for the termination of early pregnancy in 2000. By Allison M.

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Bill of Health

SEPTEMBER 22, 2022

These five students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard. Sarah Gabriele is a second year Master of Bioethics candidate at Harvard Medical School. We are excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. Louis (USA).

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Bioethics FDA Governance 130

Bill of Health

DECEMBER 20, 2022

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

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Bill of Health

NOVEMBER 3, 2023

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. Upon investigation, I found little to no analysis of PROMs in the legal literature, so Andy and I recently published a law review article about them.

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Malpractice Bioethics HIPAA FDA 284

Bill of Health

DECEMBER 14, 2022

In a recent article, Normalizing Reproductive Genetic Innovation , I offer four potential avenues for structuring a societal discourse in the U.S. Food and Drug Administration (FDA). For example, physicians and companies offering cytoplasmic and mitochondrial transfer have received Untitled Letters from the FDA. on the topic.

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Bill of Health

JANUARY 7, 2022

The American booster push was controversial, because the scientific evidence on the need for and effectiveness of boosters was limited, and the White House exerted an unprecedented level of pressure on the FDA and CDC’s ‘independent’ scientific review processes. Ultimately, both the FDA and CDC gave their blessing to boosters.

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