Biosimilar Regulatory solution center
-
Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
6/23/2025
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
-
How Is RIM Software Transforming Regulatory Compliance?
6/20/2025
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
-
A Look At Elsa, The FDA's New AI Digital Assistant
6/12/2025
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
-
Bracing For The Impact Of The Federal Workforce Reduction
6/9/2025
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.
-
Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services
5/22/2025
The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?
-
First AMT Program OK'd Under New FDA Designation — Here's What To Know
5/21/2025
The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.
-
Formulation Is Key For Y-mAbs' Self-Assembling Antibody
5/16/2025
The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.
-
AI's Potential To Aid Multispecific Analytical Characterization
5/16/2025
Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.
-
A Shift Towards Biofluorescent Particle Counters In Manufacturing
5/12/2025
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
-
From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
5/7/2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.