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The Food and Drug Administration (FDA) has decided to deny Yong Sheng Jiao's request for a hearing and issued a final debarment order. Jiao, who pleaded guilty to felony charges related to importing a misbranded drug into the U.S., is barred for five years from providing services connected to drug application processes. The FDA determined that the seriousness of Jiao's offense warranted this punishment, despite Jiao's claims of misunderstanding and attempts to challenge the penalty's severity. The decision reflects the FDA's commitment to maintaining the safety and integrity of the drug industry in the United States.

The Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUAs) for biological products during the COVID-19 pandemic, one requested by Pfizer, Inc., and the other by ModernaTX, Inc. These Authorizations allow the use of vaccines to help manage the public health emergency declared by the Secretary of Health and Human Services. The Authorizations include specific conditions and are part of efforts to protect public health and national security in response to the SARS-CoV-2 virus, which causes COVID-19. The FDA ensures that such products can be used when there are no adequate, approved alternatives available.

The Food and Drug Administration (FDA) has announced the revocation of the Emergency Use Authorization granted to B. Braun Medical, Inc. This authorization was for the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES, which were initially approved for emergency use during the COVID-19 pandemic. The revocation, effective October 1, 2024, follows a request from B. Braun Medical, Inc., due to a lack of customer demand and the improved COVID-19 situation. This decision ensures public health and safety is maintained.

The Food and Drug Administration (FDA) has announced the revocation of Emergency Use Authorizations (EUAs) for three COVID-19 tests developed by Beckman Coulter, Inc., including the Access SARS-CoV-2 IgG, IgM, and IgG II tests. This action was taken upon the request of Beckman Coulter, who also decided to stop the distribution of these tests as of January 1, 2025. The FDA concluded that revoking these authorizations is necessary to protect public health and safety. The revocation became effective on January 8, 2025, with detailed explanations provided for each decision.

The Food and Drug Administration (FDA) is asking the public to comment on its proposed updates to how it collects information from tobacco product establishments. These changes aim to streamline the registration and listing process for such establishments and involve revisions to forms and the use of an improved electronic portal. The updates are also expected to make the registration process simpler and more efficient. The public can submit their comments online or through mail until March 18, 2025.

The Food and Drug Administration (FDA) has denied Yong Sheng Jiao's request for a hearing and has banned him from importing or offering to import any drugs into the United States for five years. This decision stems from Jiao's conviction for importing misbranded drugs, specifically dipyrone, by mislabeling them as sebacic acid. Jiao tried to argue that he was not responsible for the misbranding, claiming it was his supplier's fault, but the FDA maintained that his guilty plea in court provided enough basis for the ban. The FDA determined a five-year ban was appropriate after weighing the seriousness of his offense against the few mitigating actions he took.

The Federal Aviation Administration (FAA) has implemented a final rule to amend and revoke certain Very High Frequency Omnidirectional Range (VOR) Federal Airways in the eastern United States. This change is part of the FAA's VOR Minimum Operational Network (MON) Program and is necessitated by the planned decommissioning of specific navigation aids in Florida. The amended airways include V-3, V-35, V-51, and several others, while airways V-295, V-529, and V-601 have been revoked entirely. This rule aims to maintain efficient and safe navigation across the National Airspace System by updating the route structure to reflect current operational needs.

BNSF Railway Company requested that the Surface Transportation Board allow a trackage rights exemption to expire at the end of 2021, as previously agreed with Union Pacific Railroad. This arrangement lets BNSF use Union Pacific's rail lines to transport trains carrying ballast to and from a pit in Elsey, California. The Board granted the request, ensuring that the agreement will conclude on December 31, 2021, without negatively impacting shippers, and included protections for any employees affected by the change. This decision will be published in the Federal Register and is effective as of March 25, 2021.

The Food and Drug Administration (FDA) has issued five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

The Food and Drug Administration (FDA) announced the user fee rates for fiscal year 2025 under the Over-the-Counter (OTC) Monograph Drug User Fee Program. This program allows the FDA to collect fees from manufacturers of OTC monograph drugs, which do not require a new drug application. For FY 2025, the fee for facilities manufacturing these drugs is set at $37,556 for monograph drug facilities and $25,037 for contract manufacturing organizations. These fees help the FDA cover the costs associated with regulating OTC monograph drugs.