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The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway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

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

Pharma Mirror

JANUARY 5, 2024

New Delhi, India – FD-AID, LLC, a distinguished leader in pharmaceutical quality and compliance solutions, proudly announces its entry into the Indian pharmaceutical market.

Compliance 130

Compliance FDA Compliance Marketing Drugs 130

Cloudbyz

AUGUST 19, 2024

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

Pharma Marketing Network

OCTOBER 24, 2024

New drugs, evolving technologies, and emerging marketing channels are creating fresh opportunities for pharma marketing executives. From targeted cancer therapies to specific drugs for chronic illnesses, pharma companies must market treatments that speak to individual patient needs. The trick is balancing engagement with compliance.

Marketing 52

Marketing Branding Pharma Companies Compliance 52

FDA Law Blog

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

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The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for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