XTalks

DECEMBER 9, 2024

Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits. The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. What is the purpose of a Design History File (DHF) in medical device development?

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Intouch Solutions

NOVEMBER 18, 2021

Case studies are in development with the preliminary data. And educational resources have been created detailing the RSA ad format to share with the audiences who review creative assets for FDA compliance. All newly created ad plans and ad plan updates will heavily feature the RSA ad format.

Branding 52

Branding FDA Compliance Marketing Regulation 52

Pharma Marketing Network

OCTOBER 24, 2024

However, with the rise of digital marketing, compliance has become more complex. Always be one step ahead by integrating compliance checks into every campaign and staying informed on FDA and EMA guidelines. The trick is balancing engagement with compliance.

Marketing 52

Marketing Branding Pharma Companies Compliance 52

XTalks

JANUARY 8, 2025

The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for integrating artificial intelligence (AI) into regulatory decisions for drug and biological product development.

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The FDAs new draft guidance for developers of AI-enabled medical devices marks a critical milestone in addressing the complexities of transparency, bias and safety throughout the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. Developers are urged to document evidence that their devices perform consistently across diverse demographic groups.

Production 105

Production Marketing Development FDA Compliance 105