Search Results for agency_names:"Food and Drug Administration"

The Food and Drug Administration (FDA) has announced an opportunity for the public to comment on a proposed information collection related to establishment registration and product listing requirements for manufacturers of human blood, blood products, and licensed devices. This notice, part of the Paperwork Reduction Act of 1995, allows 60 days for public input. Comments can be submitted electronically via the Federal eRulemaking Portal or by mail, with detailed instructions provided by the FDA. The purpose of this information collection is to aid the FDA in inspecting facilities and ensuring the safety of the nation's blood supply.

The Food and Drug Administration (FDA) is withdrawing approval for two abbreviated new drug applications (ANDAs) from Flamingo Pharmaceuticals Ltd. This decision is because the company has consistently failed to submit the necessary annual reports for these drug applications. Despite being given a chance for a hearing, the company did not respond, resulting in a waiver of their hearing opportunity and any claims about the drug's legal status. Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.

The Food and Drug Administration (FDA) issued a permanent debarment order against Alec Burlakoff under the Federal Food, Drug, and Cosmetic Act. Burlakoff was convicted of a felony involving illegal activities with a drug called SUBSYS while working at Insys Therapeutics. His actions included bribing doctors to prescribe the drug, often to patients who did not have cancer. As a result, Burlakoff is banned from providing services related to drug product applications, and there are penalties for any approved drug product applications that employ him during this period.

The Food and Drug Administration (FDA) is allowing more time for people to comment on a public meeting focused on smoking cessation. Initially, the public was given until November 21, 2024, to submit their thoughts, but due to high interest, the deadline has been extended to December 20, 2024. The meeting, held in collaboration with the National Institutes of Health, aimed to discuss new products to help people quit smoking, especially those in underserved communities. Interested parties can submit their comments electronically or in writing.

The Food and Drug Administration (FDA) has announced its determination of the regulatory review period for the human drug BYLVAY. The FDA made this determination following a request from the U.S. Patent and Trademark Office for information related to patent term restoration. BYLVAY, approved for treating pruritis in patients aged 3 months and older with progressive familial intrahepatic cholestasis, underwent 1,868 days of regulatory review, including a testing phase of 1,625 days and an approval phase of 243 days. This notice invites anyone with information suggesting that these dates might be incorrect to submit their comments for consideration.

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) has released a new guidance to help reduce the risk of transmitting Mycobacterium tuberculosis (Mtb) through human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for screening donors to check for signs and risk factors of tuberculosis infection. This document was issued urgently due to recent multistate outbreaks linked to Mtb transmissions from donors and aims to enhance screening until official tests are available. Although the guidance is effective immediately, the FDA is open to receiving comments on it.

The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development." This document was created under the International Council for Harmonisation (ICH) and provides recommendations on planning, evaluating, and documenting evidence in drug development using models. It aims to help harmonize regulations globally, enhancing drug development and improving manufacturing standards. Public comments on the draft can be submitted until February 28, 2025.

The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection for the National Agriculture and Food Defense Strategy Survey. This survey, conducted under the FDA Food Safety Modernization Act, aims to gather information from state, local, territorial, and tribal agencies on their food defense activities against intentional contamination and emerging threats. The collected data will be used in a report to Congress to assess progress in food defense. The process includes electronic and written submissions, with guidelines provided to protect confidential information.

The Food and Drug Administration (FDA) is inviting public feedback on its proposed collection of information related to adverse events and product experiences for FDA-regulated products. As part of fulfilling requirements under the Paperwork Reduction Act, the FDA seeks comments on whether this information collection is necessary, its accuracy, and ways to minimize the burden on respondents. They have updated forms and processes to standardize data collection, improve quality and clarity, and ensure confidentiality where necessary. The deadline for providing comments, either electronically or by mail, is March 18, 2025.