Search Results for agency_names:"Food and Drug Administration"

The Food and Drug Administration (FDA) announced the withdrawal of a rule that was originally published on September 20, 2024. This rule was intended to amend regulations regarding regulatory hearings before the agency. However, after receiving a significant number of adverse comments from the public, the FDA decided not to proceed with the changes. The rule is officially withdrawn as of January 17, 2025.

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 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) is organizing a public workshop titled "FY 2025 Generic Drug Science and Research Initiatives Workshop" to discuss science and research initiatives for generic drugs. The workshop will take place on June 3 and 4, 2025, at the FDA White Oak Campus in Silver Spring, MD, and will also be accessible virtually. The FDA seeks input from various interested groups, including industry professionals and patient advocates, as part of their ongoing commitment to develop annual science initiatives under the Generic Drug User Fee Amendments (GDUFA). Attendees can submit electronic or written comments about the workshop until July 7, 2025.

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.”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 released a final guidance document titled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance outlines how the FDA plans to assess the public health significance of food allergens not already classified as major allergens, like milk or peanuts. It focuses mostly on allergies caused by IgE antibodies known to trigger severe allergic reactions. The FDA also made updates in response to feedback, including changes related to non-IgE-mediated allergies and new data references.

The Food and Drug Administration (FDA) is requesting public comments on the National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. The FDA aims to gather input to develop a draft plan, which will be discussed in a public meeting scheduled for spring 2025. They are seeking feedback on how data from NARMS is used, what additional information might be valuable, and suggestions for monitoring antimicrobial resistance within the One Health framework. Comments can be submitted electronically or in writing until March 26, 2025.

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) announced the release of final guidance titled "E11A Pediatric Extrapolation," prepared with the International Council for Harmonisation. This guidance aims to streamline pediatric drug development, focusing on strategies like safety extrapolation and statistical methodologies to ensure safe, effective medicines for children. It replaces a draft guidance from August 2022 and includes updates to study designs and modeling approaches. The public can comment on this guidance, which is accessible through FDA's regulations website.

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Considerations for Complying With 21 CFR 211.110." This draft guidance aims to help manufacturers ensure the uniformity and integrity of drug products by complying with specific regulations. It also provides insight into how advanced manufacturing techniques, like 3D printing and continuous manufacturing, can be incorporated into manufacturing processes. The FDA encourages industry representatives who are interested in using innovative control strategies to contact them for further guidance.