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 Clinical Trials Clinical Trials Compliance 52

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The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway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

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Shah, M.D.,

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

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? Through continuing medical education (CME) , peer-reviewed studies , and collaborative research , pharma marketers can build strong relationships with doctors and HCPs.

Marketing 52

Marketing Branding Pharma Companies Compliance 52

Cloudbyz

AUGUST 19, 2024

Regulatory Approval: Obtaining approval from regulatory bodies, such as the FDA or EU regulatory authorities, before initiating the trial. Site Selection: Choosing clinical trial sites, such as hospitals or research institutions, that have the expertise and resources to conduct the study according to the protocol. In the U.S.,

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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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

Pharma Marketing Network

MARCH 13, 2025

By automating content research and optimization, AI ensures pharma brands stay relevant in search rankings. Patients researching chronic conditions. Can AI help with FDA compliance in pharma marketing? These tools: Generate SEO-friendly blog content on medical topics. Identify high-performing keywords for search ads.

Marketing 52

Marketing Branding Compliance Sales 52