The NAM of the Game – Navigating FDA’s Shift Toward Animal Testing Alternatives
The FDA has updated regulatory terminology so that animal studies are no longer presented as the only way to generate non-clinical safety evidence for human drugs and biological products. Learn more about about this change and how it creates more room for scientifically sound “New Approach Methodologies” (NAMS) in our latest blog.
Ready, Set, IND: FDA’s Fast-Track Pilot Explained
On 09/15/2026, the Food and Drug Administration (FDA) launched its Expedited Investigational New Drug (IND) Pilot Program and opened the window for sponsors to submit applications. This pilot will test whether earlier, rolling FDA review can accelerate promising drugs and biologics into first-in-human trials. Learn the differences between the traditional IND pathway and the expedited pilot in our latest blog!
Mastering the Protocol: FDA’s Playbook for Drug and Biologics Trials
Our latest blog covers the FDA guidance “Master Protocols for Drug and Biological Product Development.” Learn what a master protocol is, its allowance to create efficiency, and risks for manufacturers
Thinking Outside the Box… and Inside the Container: FDA’s Draft Guidance for Contained Expectations
Today's blog covers the latest draft guidance from FDA "Container Closure Systems (CCS) for Human Drugs, and Biological Products," released on 8/13/2026. Learn what manufacturers can expect, and what they should prepare for in evaluating their CCS.
M15 General Principles for Model-Informed Drug Development – What Does This Mean?
In today's blog we focus on combination drug-HCT/P (Human Cell, Tissue, and Cellular Tissue Based Product) manufacturers in tandem with the FDA's final guidance, "M15 General Principles for Model-Informed Drug Development." Learn a roadmap for considerations, and pitfalls.
In Good Vein: Introducing the Blood Banking Industry
In today’s blog, we compare the similarities and key differences between the Blood Banking industry and HCT/Ps
Don’t Let Ebola Go Viral: What HCT/P Establishments Should Review Now
On July 10th, 2026, the FDA posted an important safety communication with regard to the current Ebola outbreak in the Democratic Republic of the Congo and Uganda. Learn more about the announcement and why this matters in our latest blog.
Back to Basics: Records and Documents
In our latest “Back to Basics” blog, we cover Documents and Records. Learn the purpose, document focus, and records focus on HCT/Ps, Medical Devices, Finished Drugs, and Electronic Records and Signatures.
HALO There Elsa! FDA Expands A.I. Capabilities and Data Platform Consolidation
Our lastest blog covers the FDA’s update to ELSA 4.0 and to the inclusion of HALO (Harmonized AI & Lifecycle Operations for Data). Read more here!
FDA’s Real-Time Clinical Trial Push: Industry Information Session on Real-Time Clinical Trials Request for Information (RFI)
Our newest blog covers FDA’s pilot program for real-time clinical trials, including the advantages and challenges associated with it.
FDA’s One-Day Inspection Assessments Are Here!
Our newest blog covers the pilot program for 1 day assessments by FDA
Back to Basics Understanding FDA Labeling Requirements
The newest in the Back to Basics Series covers FDA Labeling Requirements!
CMC Flexibilities for Developing Human Cellular and Gene Therapy Products for Biologics License Application
Our latest blog covers potential flexibilities in CMC development based on the recent final guidance from FDA
Updated Computer Software Assurance for Production and QMSR Software Guidance
Our prior blog in October covered the introduction of CSA, and in February 2026, the FDA released their final guidance “Computer Software Assurance for Production and Quality System Software.” This blog covers a summary of the most recent guidance. Read more here!
Level 2 Guidance for Pyrogen and Endotoxin Testing: Q&A Edition 2
Our latest blog covers the Food and Drug Administration’s (FDA) level 2 revision ofthe final guidance, “Pyrogen and Endotoxins Testing – Questions and Answers (Edition 2)”, released in March 2026
Using New Approach Methodologies (NAMs) in Drug Development
Read here on the FDA’s recommendations in their latest draft guidance “General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development Guidance for Industry”, currently open for comments.
FDA Announcement: FDA Launches AEMS: Making Adverse Event Reports Easier to Access and Understand
Our latest blog covers the FDA’s launch of the Adverse Event Monitoring System!
FDA Draft Guidance: How to Respond to FDA 483 At the Conclusion of a Drug CGMP Inspection
Our latest blog covers the newest FDA guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, currently in its comment period.
QSit out – In with the New FDA Inspection Program!
Our lates blog covers the expiration of QSIT, and the new Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). Find out key differences here!
Electronic Signatures and Electronic Records 21 CFR Part 11 Overview
Our latest blog explores 21 CFR Part 11 Electronic Records; Electronic Signatures. What are the regulatory requirements and how implementation can streamline your business?