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Read here on the FDA’s recommendations in their latest draft guidance “General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development Guidance for Industry”, currently open for comments.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FDA Draft Guidance: How to Respond to FDA 483 At the Conclusion of a Drug CGMP Inspection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?
Bayes-ically Speaking: FDA’s Draft Guidance on Bayesian Statistics for Clinical Trials Opens for Comment
Bayes-ically covering the FDA’s guidance on Bayesian Statistics
FDA Increases Flexibility Requirements for Cell and Gene Therapies Advancement
On January 11, 2026, the Food and Drug Administration (FDA) announced it was sharing information about the Agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies. See what this means for your organization!
Donor Screening: The Case of Rabies Transmission
Today’s blog highlights a recent rabies transmission case and associated CDC recommendations
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
In our lastest blog, we outline the recent guidance from FDA on the use of real world evidence to support medical device regulatory decisions.
Biosimilar & Interchangeable Biosimilar Products: Considerations for Promotional Labeling and Marketing
Biosimilars- Regulatory considerations and overview for promotional materials!
I SOoooo Want to know More About ISO/IEC 27002:2022 for Information Security,Cybersecurity and Privacy Protection (part 2)
In Part 2 of our returning, “I SOooo Want To Know” series of blogs, we dive into ISO 27002:2022!
Extra! Extra! Read All About the AATB Updates!
There’s been a large amount of new developments with the AATB. Learn more from our lates blog here!