ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

FDA Compliance 52

FDA Compliance Compliance Clinical Trials Clinical Trials 52

XTalks

JANUARY 8, 2025

Transparency is especially important in addressing the ‘black-box’ nature , where users and regulators may not know why an AI model reaches a particular conclusion, which often makes these systems harder to trust. To comply, sponsors need to ensure AI models are transparent, reproducible and suited to their specific context.

Development 105

Development Drugs Compliance Clinical Trials 105

XTalks

JANUARY 9, 2025

The FDAs new draft guidance for developers of AI-enabled medical devices marks a critical milestone in addressing the complexities of transparency, bias and safety throughout the lifecycle of these advanced technologies.

Production 105

Production Marketing Development FDA Compliance 105

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

Intouch Solutions

NOVEMBER 18, 2021

While RSAs have been around since 2019, pharma and other regulated industries have been slow to adopt them because of the inherent lack of control of the ad elements that is given to advertisers. Concerns for Pharma Marketers Special care must be taken to accommodate the stringent regulations for pharmaceutical ads. Source: Google.

Branding 52

Branding FDA Compliance Marketing Regulation 52

FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

Compliance 52

Compliance Manufacturing Regulation Marketing 52