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At the 2025 Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference, senior ...
In 2026, regulators across major markets are signaling a shift toward risk-based supplier management—and companies ...
Industry groups are calling for the withdrawal of multiple draft guidances related to 510(k) submissions and the ...
The US Food and Drug Administration has issued its final guidance outlining expectations for promotional labeling ...
European lawmakers have reached a provisional agreement on the most comprehensive overhaul of the European Union’s ...
A newly proposed draft guidance on the development of regenerative medicine therapies has prompted significant ...
EMA Explores New Biomarkers and Patient Populations in Proposed Parkinson’s Disease Guideline Update
The European Medicines Agency (EMA) has released a concept paper outlining proposed updates for its clinical ...
EMMA International is proud to announce that it has been awarded the EurAsia Gulf Excellence Award. This ...
The U.S. Food and Drug Administration (FDA) has released new draft guidance that could significantly reduce the ...
More than five years after ranitidine products were withdrawn due to concerns about nitrosamine contamination, a ...
A sharp rise in enforcement actions has defined fiscal year 2025 for the Center for Drug Evaluation and Research ...
Emma International is proud to announce the launch of its GCC Services division. This expansion strengthens EMMA ...
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