Search Results for keywords:"drug approval process"

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

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 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.

The Department of Health and Human Services has released a statement about improving transparency in the drug approval process by the Food and Drug Administration (FDA). They examined how long it takes the FDA to review and approve new drug applications. Historically, Congress set a 180-day limit for this process, but recent reviews show that it often takes longer. To improve transparency and accountability, the FDA will now publish detailed timelines of these reviews on its website so the public and Congress can better understand these processes and their impacts.