Bill of Health

NOVEMBER 29, 2023

By Vincent Joralemon Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals. This patent gives someone the motivation to fund FDA trials.

FDA 263

FDA Pharmaceutical Industry Licensing 263

SQA

JUNE 3, 2024

The Administrative Measures are comprised of the following seven chapters, encompassing a total of 79 articles that mainly address the administration of drug supply licenses, obligations of businesses supplying drugs and medical institutions using drugs, as well as regulators supervision of stakeholders in drug supply and use.

FDA 40

FDA COVID-19 Licensing Nurses 40

Bill of Health

SEPTEMBER 28, 2023

Senator Sanders’ proposal within PAHPA was ultimately struck from the next iteration of the legislation due to concerns from the pharmaceutical industry and others that such a measure would chill innovation. Federal support by BARDA and the CDC have de-risked the development of medical products for the pharmaceutical industry.

COVID-19 208

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 208

Hall Render

FEBRUARY 18, 2022

License wait times reach crisis levels for healthcare workers. Meet new FDA chief Dr. Robert Califf: 5 things to know. Outpatient push being felt in architecture industry. Bill on prescription drug pricing inspires support from Maine residents, opposition from pharmaceutical industry.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 40

FDA Compliance COVID-19 Public Health 40

Healthcare IT Today

JANUARY 9, 2023

The challenge to accessing this data has always been technical – with teams needed to facilitate clunky data sharing between a retail pharmacy and a drug manufacturer, or a healthcare system signing a licensing agreement with a vendor and building pipelines to ingest 3rd party data into systems of record.

Pharmaceutical Industry 85

Pharmaceutical Industry Medicare Medicare FDA 85