Access barriers to CAR-T cell therapies abound but the FDA is aiming to break some. Last week, the agency dropped some labeling requirements and eased restrictions on which facilities can administer the treatments, addressing a bottleneck limiting broader use of cell therapy.

The requirements are part of a safety program meant to mitigate the risks associated with CAR-T therapies, but the agency decided hospitals are familiar enough with the associated syndromes that the labeling is no longer required. The changes impact Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson and Novartis, which have CAR-T therapies for blood cancer, as well as smaller biotechs poised for entry.

Carving away restrictions isn’t the only way the FDA is changing the regulatory process around drug access. The agency also aims to expedite reviews for drug approvals, which could give patients access to treatments sooner. Today, we’re diving deeper into the agency’s proposed accelerated review programs and what they could mean for drugmakers.

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