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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 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 Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.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) has delayed the effective date of the rule defining the term "healthy" on food labels from February 25, 2025, to April 28, 2025, following a presidential memorandum on regulatory freeze. The rule updates how and when the term "healthy" can be used to help consumers identify nutritious foods according to current dietary guidelines. This delay allows for additional review, and although the rule's compliance date isn't until 2028, companies can start following it before then if they choose.

The Food and Drug Administration (FDA) has announced that it received approval from the Office of Management and Budget (OMB) for a collection of information titled the "National Agriculture and Food Defense Strategy Survey". This approval was granted under the Paperwork Reduction Act of 1995 and is valid until November 30, 2027. The survey is designed to gather information and support strategic planning in agriculture and food defense. The approval is marked with the OMB control number 0910-0855.

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 United States Patent and Trademark Office has granted a one-year interim extension for U.S. Patent No. 6,953,476, which belongs to Neovasc Medical Ltd. This patent covers an implantable device called Reducer®, and the extension was needed because the regulatory review by the Food and Drug Administration is expected to take longer than the patent's original expiration date. The extension allows Neovasc more time to prepare while waiting for the FDA's approval process to conclude.

The document is a correction notice from the Food and Drug Administration and the Health and Human Services Department. It relates to a previous notice about the export of FDA-regulated products, specifically changing a date in the document. The correction changes the date in the "DATES" section from January 20, 2021, to January 21, 2021. This update ensures that the information is accurate for those referencing the document.

The Food and Drug Administration (FDA) announced the availability of guidance documents related to the COVID-19 public health emergency. The guidance has been released without prior public comment to expedite the response to the pandemic but remains open for public input. Electronic or paper comments on these documents can be submitted through designated channels. These guidelines reflect the FDA's current practices and do not impose any binding obligations but serve as recommendations for the industry and relevant stakeholders.

The Food and Drug Administration (FDA) is announcing a virtual public meeting titled "Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards," to be held on April 7, 2021. The meeting aims to gather stakeholder feedback on FDA's electronic submission system, data standards, and technology initiatives. Individuals can submit comments electronically or in writing by March 7, 2021. This information will help inform the FDA's IT Strategic Plan and related electronic submission processes.

The Food and Drug Administration (FDA) has announced that they approved the use of ALYFTREK, a drug made up of vanzacaftor, tezacaftor, and deutivacaftor, on December 20, 2024. This approval includes the use of a priority review voucher, which is a special designation given to sponsors of drugs for rare pediatric diseases. These vouchers are part of a program designed to encourage the development of treatments for rare conditions found in children. For more information, individuals can visit the FDA's official website linked in the document.