Search Results for keywords:"FDA"

The Food and Drug Administration (FDA) has released a draft guidance titled "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices." This document aims to help sponsors, clinical investigators, and institutional review boards define, identify, and report protocol deviations effectively during clinical investigations. It offers definitions and a classification system for reporting these deviations, allowing consistent documentation and interpretation. Comments on the draft can be submitted electronically or in writing by February 28, 2025, to help shape the final guidance.

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 Food and Drug Administration (FDA) has determined the regulatory review period for a human biologic product named OMISIRGE, which is used for treating certain blood cancers. The review period, which is 4,563 days long, involves a testing phase and an approval phase and influences the potential extension of the product's patent. The FDA's decision follows an application by Gamida Cell Ltd. for patent extension, and the public can provide comments or request further determinations by specified deadlines.

The Food and Drug Administration (FDA) has released a final guidance document for the pharmaceutical industry called the "Advanced Manufacturing Technologies Designation Program." This program aims to encourage the adoption of advanced manufacturing technologies (AMTs) that can enhance drug quality and production efficiency. The guidance outlines eligibility criteria, submission processes, and benefits for obtaining an AMT designation, which supports the development of crucial drugs. Additionally, it finalizes a draft from December 2023 and reaffirms FDA's commitment to improving drug manufacturing processes.

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 calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.

The Food and Drug Administration (FDA) is conducting a survey to gather information from facilities that manufacture, process, or pack drug products. This survey aims to understand how these facilities manage risks related to the quality of drug components, containers, and supply chains. The data collected will help the FDA analyze potential updates to manufacturing regulations for drugs. The public is invited to submit comments on this information collection by February 16, 2021.

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 withdrawing approval of seven new animal drug applications because the companies responsible for these drugs repeatedly failed to submit the required annual reports. The FDA had previously offered these companies the chance for a hearing, but they did not respond, which meant they gave up that opportunity and any arguments about the legal status of the drugs. As a result, these drug approvals will no longer be valid starting February 23, 2021.

The United States Patent and Trademark Office (USPTO) has granted a one-year interim extension for U.S. Patent No. 7,534,790, which covers the drug vernakalant hydrochloride. The extension was necessary because the regulatory review by the Food and Drug Administration (FDA) will extend beyond the patent's expiration date of March 31, 2021. Correvio International Sàrl, the patent owner, applied for this third interim extension as allowed under U.S. patent law for certain cases where market approval is pending. This extension ensures the patent remains valid while the review process continues.