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The Food and Drug Administration (FDA) has issued an order permanently banning John Warrington Kosolcharoen from working with companies that have approved or pending drug product applications. This decision resulted from his felony conviction for fraudulently selling an unapproved stem cell product, ReGen, and making misleading claims about its safety and effectiveness. Mr. Kosolcharoen was given the chance to challenge the debarment but did not respond in the provided timeframe, leading to a waiver of his right to a hearing on the decision. During his debarment, any business that employs him for related services could also face penalties.

The Food and Drug Administration (FDA) has made available a final guidance document titled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates a previous version and includes a list known as the 506J Device List, which outlines device product codes that manufacturers must notify the FDA about if they stop production. The document clarifies that manufacturers can also voluntarily notify the FDA of any supply chain issues, regardless of public health emergencies. This guidance aims to facilitate continuous device supply and prevent shortages.

The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to medical device shortages. Under the Paperwork Reduction Act, they must announce proposed data collection plans and allow a 60-day public comment period. This data will help the FDA manage medical device availability during emergencies by obtaining information on production changes that could cause shortages. Additionally, the CARES Act gives FDA the power to require notifications from manufacturers about disruptions that could impact device supply, especially during public health emergencies.

The Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.

The FDA has issued a final debarment order against Alnashir Alibhai Punjani, prohibiting him from importing or attempting to import any drugs into the U.S. for five years. This decision is because Mr. Punjani was found guilty of conspiring to import and sell unapproved drugs. The drugs he imported and resold contained sildenafil, an ingredient used in Viagra, and were not approved by the FDA, raising potential health risks. Mr. Punjani did not respond to the notice of debarment, waiving his right to contest the decision.

The Food and Drug Administration (FDA) has released a draft guidance for industry on the process of notifying them about a permanent discontinuance or an interruption in the manufacture of infant formula. This guidance aims to assist those in the infant formula industry in complying with notification requirements to the FDA, as mandated under the Federal Food, Drug, and Cosmetic Act. The guidance outlines how and when manufacturers should notify the FDA in order to avoid potential disruptions in supply. The public is invited to submit comments on the draft guidance until February 18, 2025, and on the proposed collection of information by February 3, 2025.

The Food and Drug Administration (FDA) is collecting information regarding humanitarian use devices (HUDs), which are medical devices meant for conditions affecting fewer than 8,000 people in the U.S. The FDA seeks public comments on this information collection by March 26, 2021, to help decide whether these devices should be exempt from certain effectiveness requirements. This effort is in accordance with the Paperwork Reduction Act and aims to ensure that those with rare conditions have access to necessary medical devices without significant safety risks. Additionally, the FDA updated estimates of the time and resources needed for this data collection to reflect more current information.

On January 30, 2024, the Canadian National Railway Company and Grand Trunk Corporation filed an application to take control of Iowa Northern Railway Company. The Surface Transportation Board approved the application, requiring a three-year period of oversight to ensure compliance and effectiveness. During this time, the applicants are obliged to provide regular reports on service, operations, and competition metrics. In response to concerns about confidentiality, the Board adjusted reporting requirements to balance transparency with the protection of sensitive data.

Grainbelt Corporation, a smaller railroad company, has applied for an exemption to extend its use of tracks owned by BNSF Railway Company in Oklahoma and Texas. This extension allows Grainbelt to transport trains for BNSF customers and access a specific facility in Oklahoma until March 2026. The Surface Transportation Board notes that employees affected by this change will receive protections, and any challenges to the exemption need to be filed before May 1, 2025. Additionally, this action is environmentally cleared and doesn't require historic preservation reports.

The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995. The information collection supports the establishment of the Advanced Manufacturing Technologies (AMT) Designation Program as authorized by the Federal Food, Drug, and Cosmetic Act. This program encourages the pharmaceutical and biologic industries to adopt new manufacturing technologies to help with the development and availability of critical medical products. The FDA has also published draft guidance for this program, inviting public feedback to refine and improve the implementation process.