FDA proposes new treatment approval pathway for ultrarare diseases

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
Fierce Biotech

FDA illuminates new approval pathway for bespoke gene editing therapies

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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...
Law

FDA Offers Up New Pathway for Drugs That Can't Clear Normal Approval Hurdles

“Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I follow the larger concept at play here, which is FDA willingness to be ...

FDA unveils new pathway for approving customized treatments for rare diseases

The FDA has proposed new guidelines to facilitate the approval of customized treatments for rare diseases, aiming to address ...