Submissions and Approvals

FDA Sets Limits on Fecal Matter Transplant

The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More

FDA Proposes Giving More Combo Drugs Five-Year Exclusivity

The FDA is proposing to extend new chemical entity (NCE) market exclusivity for certain fixed-dose combination (FDC) drugs from three to five years, bowing to industry and congressional demands that more incentives are needed to pursue the costly products. Read More