LPAD Approval Pathway Is Not Saving Antimicrobial Development

US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.

Bundle of money and pack of medication tablets or drug pills, close-up. Expensive health care concept, selective focus

One of the US FDA's newest weapons to help spur antimicrobial development may not be as vital as initially thought. However, industry still needs incentives and now the agency is moving into the reimbursement area to fight against antimicrobial resistance.

The Limited Population Antibacterial Drug (LPAD) pathway allows antibiotics to be approved and labeled for small populations with unmet needs. The program is intended to allow smaller clinical trials and...

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