The publication of this first book addressing global regulation of regenerative medicines marks a seminal moment in the evolution of the regenerative medicine industry. By compiling all the relevant ...

This event will share an update to the AI landscape, including challenges to AI development, standards & regulations to address these challenges, and a deeper dive into AI risk and AI cybersecurity.

Gene therapies have the potential to revolutionize disease treatment by addressing underlying genetic disorders, offering a beacon of hope in healthcare. However, their complexity and the rapidly ...

Recon: Lilly to acquire Verve in potential $1.3B deal; RFK Jr. eyes crackdown on drug ads ...

Head of Education Programs Location: Rockville, MD (Hybrid or Remote) Key Skills: Program planning, budgeting, managing, and implementing Experience: 4-6 years of experience Reports to: Senior VP of ...

Learning Objectives At the conclusion of this workshop, participants should: Be familiar with various types of biologic products and their structural/functional characteristics Understand development ...

Explore why styles guides and lexicons are indispensable for document quality and learn how to adapt them as a standard for every document that the team writes.

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in requesting meetings with the agency following the receipt of a warning letter. Requesting these meetings was a ...

The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) have jointly published a glossary of real-world evidence/real-world data (RWD/RWE) terms intended to improve ...

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is running a consultation on plans to add potency information to the labels of topical corticosteroids. Topical corticosteroids ...

UK's NICE says Lilly, Eisai's Alzheimer's drugs aren't worth national coverage (Endpoints) Trump aid cuts deal a blow to HIV prevention in Africa (Reuters) China's Sciwind's GLP-1 shows similar weight ...

Corrigan-Curay began her career at FDA as CDER’s Director for the Office of Medical Policy (OMP) in October 2016. She eventually stepped into the role of acting CDER director when former CDER Director ...