Newsletter - January 18, 2024
FDA Lists Major Compliance Findings from Its Drug Audits in 2023
This week the FDA released its annual report on compliance inspections listing key observations made by its inspectors, giving current trends in non-compliance activities and related FDA enforcement activities. The report provides an overall picture of what FDA inspectors look for at the facilities they are auditing...Read More
Using ChatGPT to Write Informed Consent for Clinical Practice and Clinical Trials
Informed consents from patients/subjects are critical both in clinical care and clinical trials. However, informed consents are mostly written such that it would be hard for most patients to adequately understand them leading to improper informed consent. A study published this week reports on the experience...Read More
FDA Lists Major Compliance Findings from Its Drug Audits in 2023
This week the FDA released its annual report on compliance inspections listing key observations made by its inspectors, giving current trends in non-compliance activities and related FDA enforcement activities. The report provides an overall picture of what FDA inspectors look for at the facilities they are auditing...Read More
Using ChatGPT to Write Informed Consent for Clinical Practice and Clinical Trials
Informed consents from patients/subjects are critical both in clinical care and clinical trials. However, informed consents are mostly written such that it would be hard for most patients to adequately understand them leading to improper informed consent. A study published this week reports on the experience...Read More
