Testosterone replacement therapy in 2026: A guide to the latest FDA guidance and what’s changed

The 2026 proposal is seemingly shifting the TRT landscape, moving it further from the “use with caution” territory.
MedTech Dive

The FDA was all in on AI. Will that change?

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.
BioProcess International

Paradigm Shift in Chemistry, Manufacturing, and Controls: The FDA’s Finalized Flexible Framework for Cell and Gene Therapy Approvals

The FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...
Regulatory Affairs Professionals Society

FDA drafts guidance on container closure systems, device constituents for biosimilars

The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary ...

FDA panel recommends loosening regulations for some peptides

The FDA panel will review seven peptides and decide if they should be added to a list of substances that can be safely ...
RAPS

FDA updates product-specific guidelines for injectable peptides

The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide ...
FiercePharma

FDA finalizes guidance on promotional materials for biologics and biosimilars

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...

The New Rules Of AI Drug Discovery: Three Must-Know Guidelines

The joint guidelines state that AI should be explainable and interpretable. Drug developers can no longer submit an ...
SupplyChainBrain

Mitigating FDA Risk Through Integrated FSVP and Labeling Compliance

Evolving FDA regulations pose real risks for unwary food brands, but those who proactively  invest in compliance can transform these challenges into opportunities.