Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been ...
The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...
The aim of the pathway is to remove red tape for bespoke therapies designed for patients with rare diseases.
After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...
Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.
The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...
FDA allergen thresholds offer food brands science-based guidance on managing cross-contact risks and using advisory ...
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