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Voters first approved $10 billion in bond money in 2008 for a project designed to shuttle riders between San Francisco and Los Angeles in less than three hours. ... The Trump administration is ...
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
The Presidential Appointment Efficiency and Streamlining Act of 2011 (Pub. L. 112–166 (text)), signed into law on August 10, 2012, eliminates the requirement of Senate approval for 163 positions, allowing the president alone to appoint persons to these positions: [7] Parts of the act went into effect immediately, while other parts took effect ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
In August 2024, the US Food and Drug Administration granted accelerated approval to Adaptimmune's Tecelra, a therapy against a rare form of cancer. Tecelra is the first T cell therapy to be approved for use against a solid tumor.
In 2018 and 2019, BLM also approved fewer than 300 permits per month, but monthly permits jumped to 452 in 2020 as fossil fuel companies stocked up on them in anticipation of an administration ...
Download all attachments in a single zip file, or download individual attachments. While this is often a seamless process, you should also be aware of how to troubleshoot common errors. Emails with attachments can be identified with Attachment icon in the message preview from the inbox. Download all attachments
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...