The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA. The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.”
The Agency has determined that the state of irradiation sterilization is scientifically advanced to the point that this type of oversight is not necessary to protect the public health. This also means that now a product which complies fully with an OTC monograph will no longer have to be submitted and approved under an NDA or ANDA, if it uses irradiation as a means of sterilization, or if it meets all other applicable regulatory and cGMP requirements. The full Notice can be found here.
The Notice also states that “[a]ny final rule that results from this proposed rule will be effective 30 days after the date of the final rule’s publication in the Federal Register.” So, don’t jump the gun!