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The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for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

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

The trick is balancing engagement with compliance. How do you market a new diabetes drug like Trulicity or Ozempic while maintaining FDA compliance? Companies that commit to green practices and ethical drug development are more likely to win the loyalty of both healthcare professionals and patients.

Marketing 52

Marketing Branding Pharma Companies Compliance 52

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. What is the purpose of a Design History File (DHF) in medical device development? These standards are designed to mitigate risks, enhance device performance, and protect patient safety.

Compliance 52

Compliance Manufacturing Regulation Marketing 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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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The FDAs new draft guidance for developers of AI-enabled medical devices marks a critical milestone in addressing the complexities of transparency, bias and safety throughout the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