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.”

Public Health 313

Public Health FDA Bioethics Governance 313

Bill of Health

NOVEMBER 30, 2022

Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public.

FDA 176

FDA Bioethics Public Health Governance 176

Bill of Health

JANUARY 7, 2022

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures. Ultimately, both the FDA and CDC gave their blessing to boosters.

Public Health 339

Public Health FDA Governance COVID-19 Vaccine 339

Bill of Health

MARCH 7, 2024

Note: FDA approval for at least one indication is necessary for other “off-label” uses of the drug. You need one FDA approval to open the door to other off-label uses. Remember — no other psychedelic is FDA-approved ( yet ). Leveraging Public Opinion to Serve Public Health Again, this is not necessarily problematic !

FDA 111

FDA Telemedicine Public Health Doctors 111

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. Health Pol’y, Law, and Ethics 1 (2023). The post Key Considerations for Patient-Reported Outcome Measures first appeared on Bill of Health.

Malpractice 284

Malpractice Bioethics HIPAA FDA 284

Bill of Health

MARCH 28, 2022

Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2. By James Lytle. Recent guidance from the U.S. less likely to receive the treatment than whites.

COVID-19 246

COVID-19 Public Health FDA Hospitals 246

Bill of Health

SEPTEMBER 28, 2023

Public Health Service and the National Institutes of Health (NIH) incorporated a fair pricing condition as part of cooperative research and development agreements (CRADAs) between federal laboratories and private manufacturers. In 1989, the U.S.

COVID-19 205

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 205