Bill of Health
NOVEMBER 30, 2022
Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. State pharmaceutical bans and restrictions — which are often medically unnecessary and instead based largely on policymakers’ moral and political views — impede the FDA’s mandate to protect and promote the public health.
Bill of Health
APRIL 6, 2022
MDMA clinical trials are nearing completion and expected to result in FDA approval. For instance, in New York Magazine and Psymposia’s popular podcast, Cover Story: Power Trip , multiple participants went on record saying that they were pressured to use higher doses of MDMA in a MAPS clinical trial for PTSD, which later haunted them.
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Exeed Regulatory Compliance
MARCH 21, 2020
Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. According to a recent Science Magazine article , South Korea tested more than 270,000 people, which amounts to about 5200 tests per million! References Science Magazine – Coronavirus cases have dropped sharply in South Korea.
Healthcare IT Today
APRIL 9, 2023
Handheld ultrasound device maker Butterfly Network received FDA received 510(k) clearance for Auto B-line Counter , which evaluates lung ultrasound images. Synapse Biomedical received premarket approval form the FDA for NeuRx Diaphragm Pacing System , which helps patients with spinal cord injuries breathe without a ventilator.
Bill of Health
FEBRUARY 27, 2024
Both Robert and Valentina Wasson published sensational magazine articles in Life! More meaningful diversity and equity considerations remain absent from the regulatory process; for example, in June 2023, the HHS, FDA, and CDER released a draft guidance document for the clinical investigation of psychedelic drugs.
Health Populi
AUGUST 12, 2020
The photo is an illustration I cut out of a magazine of people wearing m asks from different walks of life and demographics. A n “umbrella” was also called into play by the FDA , which streamlined clinical trial protocols to expand the possible candidates for coronavirus treatments. R is for risk.
HIT Consultant
MAY 31, 2023
Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production.
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