Exclusive Analysis

Explore expert analysis of the regulatory developments shaping life sciences and food. AgencyIQ’s regulatory specialists go beyond the latest updates to explain what is changing, why it matters and what your organization should watch next—giving you the clarity and context to anticipate impacts and make more confident decisions.

Life Sciences Analysis

FDA’s new GenAi draft framework: Risk assessments and extended responsibility

By Laura DiAngelo, MPH

Exclusive Analysis

FDA’s new GenAi draft framework: Risk assessments and extended responsibility

FDA finalizes long-awaited fresh-cut produce guidance as outbreaks put prevention in focus

Heidi Overton is Trump’s pick for next FDA commissioner. Here’s what to know.

At MDUFA VI meeting, FDA revealed fee updates, program changes and next steps

FDA’s GRAS rule is here, with mandatory notification, streamlined reporting – and some exemptions

Advisory panel votes pressure FDA to allow access to compounded peptides

Companies look to federal preemption to fend off California UPF lawsuit, invoking Supreme Court pesticide case

What to make of the FDA’s latest CRL drop

The 2026 Unified Agenda is out: Here’s what it covers in food and chemicals regulation

Making sense of Operation TrialBlazer: What’s in HHS’s research reform plan

California’s food allergen labeling law to hit menus July 1

New House bill seeks overhaul of laboratory developed test regulation

House advances Ag-FDA funding bill with new food regulatory directives

Final human factors submissions guidance offers revamped documentation system

FDA nears next Closer to Zero milestone with forthcoming cadmium guidance

More FDA leaders are departing. Here’s what the turmoil may mean for agency policies and priorities

FDA finalizes postmarket food chemical assessment framework

ODAC meeting Part 1: FDA’s advisors unconvinced of ctDNA strategy for metastatic breast cancer

House hearing on FDA food regulation spotlights coming debate over scope and scale of reforms

FDA fills out genome editing product guidance with new safety recommendations

Stakeholders split in feedback to FDA on BHA’s safety and use in foods

FDA’s FY 2027 budget request previews agency priorities, reduced appropriated funding

FDA maps out scientific agenda for Human Foods Program

New FDA guidance encourages NAMs adoption, but keeps advice broad

How stakeholder feedback might shape a federal definition of ultra-processed foods

Nitrous oxide faces EU consumer ban under REACH proposal

White House reviewing FDA proposed rule on distributed manufacturing, foreign facility registration

Prevention and treatment a major focus of FDA’s food allergy regulatory push

Senate TSCA draft redefines conditions of use, adds tiered review system

FDA emphasizes study quality in shift to one-trial default for drug approval

FDA clarifies applicability of food traceability rule with new draft Q&A guidance

FDA revokes AOAC methods of analysis policy, affecting food and cosmetic testing

FDA publishes draft guidance detailing agency authority over cosmetic records