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The Food and Drug Administration (FDA) is seeking public comments on a proposed collection of information as part of its requirement for the Office of Management and Budget (OMB) review under the Paperwork Reduction Act of 1995. This initiative pertains to the application process for FDA approval to market new drugs, covering the submission of data and patent details as specified in FDA regulations. The FDA has developed specific forms to aid applicants and has made updates to the process to improve efficiency. Public comments on these proposals are welcomed by March 18, 2021.

The Food and Drug Administration (FDA) announced the determination of the regulatory review period for the drug SOHONOS, which is used to treat fibrodysplasia ossificans progressiva in certain children and adults. This determination is related to a patent extension application made to the U.S. Patent and Trademark Office (USPTO). FDA found that the drug underwent a lengthy review process, including 6,657 days of testing and 869 days of approval proceedings. People who believe any of the review dates are incorrect can submit comments to FDA, and petitioners can also request a review of the applicant's diligence during this period.