European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

Medicine 105

Medicine Food and Drug Administration Ethics Government 105

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. There is growing awareness of the importance of implementing robust data governance frameworks and compliance programmes to ensure the integrity of data.

Government 98

Government Pharma Training Ethics 98

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. The post Why Is FDA Issuing Fewer Marketing Violation Letters?

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. cited 2023Dec]. Machine Learning in Medicine.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

Clarivate

MARCH 17, 2022

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

Nixon Gwilt Law

APRIL 22, 2024

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

Nixon Gwilt Law

APRIL 22, 2024

Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). The HTI-1 Final Rule is an AI disclosure and governance rule published by the US Department of Health and Human Services (HHS).

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52