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The Surface Transportation Board reviewed a petition from the Seven County Infrastructure Coalition to build an 85-mile railway in Utah to connect the Uinta Basin with the national rail network. The Coalition seeks an exemption from the usual prior approval requirements, arguing that the rail line will provide critical transportation benefits and support local industries. While there is significant support, including endorsements from state officials, there is also opposition citing financial viability concerns and potential environmental impacts. The Board has made a preliminary decision on the transportation merits but will only finalize its decision after completing an environmental review.

The Food and Drug Administration (FDA) has issued a final order denying Bernardo Garmendia's request for a hearing and has permanently banned him from providing services related to drug products. This decision stems from Garmendia's conviction for conspiracy to commit wire fraud while working at AMB Research Center, where he was involved in falsifying clinical trial documents. As of March 14, 2025, using Garmendia’s services in any drug application process incurs civil penalties for involved parties. This ruling highlights the FDA's commitment to safeguarding drug development processes.

The Food and Drug Administration (FDA) has issued an order under the Federal Food, Drug, and Cosmetic Act to debar Harpreet Singh for 10 years from importing any drugs into the United States. This decision follows Mr. Singh's conviction for several felonies, including conspiring to distribute controlled substances like cathinone, tapentadol, tramadol, and carisoprodol, fraudulent importation and transportation of goods, conspiracy to launder money, and conspiracy to obstruct justice. The FDA based the debarment on Mr. Singh’s illegal activities related to the importation of misbranded drugs and money laundering, along with his failure to request a hearing to contest the debarment. This order takes effect on March 13, 2025.

The Food and Drug Administration (FDA) has released a new guidance document for the industry titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This document establishes the conditions for compounding certain drugs and explains the FDA’s current approach while developing a list of bulk drug substances permitted for use. This guidance replaces a previous version from 2017 and provides instructions on submitting comments to the FDA. The guidance clearly states it is not legally binding but shows the FDA's current thinking on this issue.

The Food and Drug Administration (FDA) has announced the availability of a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance details FDA's temporary rules for licensed pharmacists and physicians who are compounding drugs using bulk substances, while the agency works on creating a list of approved substances. The updated guidance finalizes the draft that was issued in December 2023 and replaces the previous 2017 guidance, ending the categorization of substances into different groups and outlining conditions under which the FDA will not take action against compounding that does not meet full compliance, while the list is still being developed. This guidance is issued as part of FDA's regulatory framework, but it does not establish any binding rights or obligations.

The Food and Drug Administration (FDA) has proposed a new rule that would require most packaged foods to display a front-of-package (FOP) nutrition label called the Nutrition Info box. This label aims to help consumers quickly find and better understand important nutrition information by providing easy-to-read details about saturated fat, sodium, and added sugars. The new rule also includes updates to regulations for low sodium and low saturated fat claims, and would allow businesses time to adjust, with compliance dates varying based on their annual sales.

The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to the registration of drug producers and the listing of drugs in commercial distribution. This effort supports the implementation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and aims to maintain up-to-date drug information to ensure public health. Key updates include exemptions for certain biological products under new guidelines resulting from the CARES Act and recommendations for emergency planning to maintain drug supply. The public can provide feedback by January 21, 2025, through the specified OMB website link.

The Food and Drug Administration (FDA) is asking public stakeholders, such as patient groups, healthcare professionals, and academics, to express their interest in joining regular consultation meetings about the reauthorization of the Medical Device User Fee Amendments (MDUFA). The FDA's authority to collect user fees for reviewing medical devices will expire in September 2022 unless new legislation is enacted. These meetings aim to gather input from various stakeholders to help shape the new MDUFA program and ensure ongoing discussions with patient and consumer groups. Interested parties should notify the FDA of their intent to participate by February 26, 2021.

The Surface Transportation Board has granted an exemption to Macquarie Infrastructure Partners V GP, LLC and other petitioners, allowing them to continue controlling North Florida Industrial Railroad, LLC (NFIR) when it becomes a Class III rail carrier. This decision was made because the exemption supports the Rail Transportation Policy by minimizing federal regulation and promoting efficient rail management. NFIR will lease and operate a track in Columbia County, Florida, connecting it to an existing rail line, which will expand transportation options for local businesses without negatively impacting any existing railway services. The effective date for this exemption is April 11, 2025.

The Food and Drug Administration (FDA) has amended regulations to allow the safe use of myoglobin as a color additive in plant-based ground meat and poultry alternatives. This rule comes in response to a petition from Motif FoodWorks, Inc., and establishes that the myoglobin used must not exceed 2% by weight of the uncooked product. The additive, produced through the fermentation of genetically engineered yeast, imparts a red color similar to raw meat. The FDA has concluded that this use is safe and does not require certification to protect public health. This rule takes effect on February 19, 2025, with a window for objections lasting until February 18, 2025.