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- Public Inspection
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Orange Book--Questions and Answers.'' This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively...
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare...
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public regarding practical...
Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). We are soliciting comments on the types of patents currently...
Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange Book”); Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit comments on FDA's publication entitled ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). The Orange Book identifies drug products approved by FDA under the Federal Food, Drug,...