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.
BioPharma 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.
The Washington Post

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...
FoodNavigator

FDA’s 2025 Food Agenda: What industry must know

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...

FDA panel recommends loosening regulations for some peptides

The FDA panel is reviewing seven peptides and deciding if they should be added to a list of substances that can be safely ...

What Marty Makary Actually Got Done As FDA Commissioner

Marty Makary resigned as FDA commissioner amid controversy. But his reforms to drug review times and AI are the agency's ...
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.
JD Supra

You Can’t Call It Cheatin’: FDA Draft Guidance Provides a Framework for Leveraging Prior Knowledge in Genome Editing Product Development

You can’t call it cheatin’, she reminds me of you,” the Gin Blossoms sang on their 1996 album Congratulations I’m Sorry. For sponsors ...
RAPS

FDA's proprietary name guidance seeks to avoid medication errors

The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs. The best ...
RAPS

FDA issues final guidance on rare disease drug development

FDA issues final guidance on rare disease drug development The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural ...