Search Results for keywords:"regulatory review period"

The Food and Drug Administration (FDA) has calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.

The Food and Drug Administration (FDA) has determined the regulatory review period for a human biologic product named OMISIRGE, which is used for treating certain blood cancers. The review period, which is 4,563 days long, involves a testing phase and an approval phase and influences the potential extension of the product's patent. The FDA's decision follows an application by Gamida Cell Ltd. for patent extension, and the public can provide comments or request further determinations by specified deadlines.

The Cboe EDGX Exchange filed a proposal with the Securities and Exchange Commission (SEC) to list and trade options on certain Ethereum Trust ETFs. This proposal was filed on February 5, 2025, and an amendment followed on February 6, 2025. The SEC has decided to extend the standard 45-day review period to give it additional time to consider this proposal, setting a new deadline of May 27, 2025, to make a decision. No public comments were received on the proposal.

The Food and Drug Administration (FDA) has determined the regulatory review period for the drug XTAMPZA ER, which is used for managing severe pain requiring long-term opioid treatment. This review is necessary for a possible extension of the drug's patent, as requested by Collegium Pharmaceutical, Inc. The review period comprises 3,214 days, with 2,712 days for testing and 502 days for approval. The FDA invites comments on this determination and allows for petitions if there are disagreements concerning the information or the due diligence during the review process.

The Food and Drug Administration (FDA) has announced its determination of the regulatory review period for the human drug BYLVAY. The FDA made this determination following a request from the U.S. Patent and Trademark Office for information related to patent term restoration. BYLVAY, approved for treating pruritis in patients aged 3 months and older with progressive familial intrahepatic cholestasis, underwent 1,868 days of regulatory review, including a testing phase of 1,625 days and an approval phase of 243 days. This notice invites anyone with information suggesting that these dates might be incorrect to submit their comments for consideration.

The Food and Drug Administration (FDA) has announced the regulatory review period for NEXOBRID, a product used for eschar removal in adults with certain types of burns. This review period is relevant to an application for patent term extension submitted to the U.S. Patent and Trademark Office (USPTO) by MediWound, Ltd. The FDA determined that the total regulatory review period for NEXOBRID was 7,427 days, with a request for a 5-year patent extension being made. The public can submit comments on this determination until February 28, 2025, and may petition the FDA to review whether the applicant acted with due diligence during this period by June 30, 2025.

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.

The Food and Drug Administration (FDA) has calculated the regulatory review period for the human drug product VEOZAH, which is used to treat menopause-related symptoms. This review period consists of 2,573 days, split between the drug testing phase (2,248 days) and the approval phase (325 days). The announcement is necessary due to requests for patent term extensions filed with the U.S. Patent and Trademark Office. The FDA invites comments and petitions regarding the accuracy of these dates and the diligence of the applicant during the review process.