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The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance titled "E6(R3) Good Clinical Practice: Annex 2," originally announced on December 30, 2024. This guidance provides updated recommendations on clinical trial design and conduct, especially those involving digital elements and real-world data. The reopening is intended to give people more time to submit comments by March 31, 2025, before the final version is prepared. The FDA made this decision following requests for extra time to develop more comprehensive feedback.

The Food and Drug Administration (FDA) has issued a final rule establishing new guidelines for nonprescription drugs that require an "Additional Condition for Nonprescription Use" (ACNU). This rule allows drugs that can't be safely used with labeling alone to be sold without a prescription if the manufacturer implements an approved ACNU to ensure proper use. It aims to expand consumer access to certain drugs that would otherwise need a prescription and outlines specific requirements for drug application, labeling, and reporting failures of the ACNU process. The rule will take effect on January 27, 2025, and is intended to improve public health by making more medications safely available as nonprescription options.

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 The rule is officially withdrawn as of January 17, 2025.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) is giving people more time to comment on a notice about certain drug ingredients they are considering for inclusion or exclusion on a special list called the 503B Bulks List. The initial comment period ended on September 29, 2020, but due to requests for more time, especially because of COVID-19 challenges, the FDA has reopened the comment period until February 8, 2021. The original list includes four ingredients proposed for inclusion and 19 others that FDA suggests not to include. Interested parties can submit their comments electronically or in writing, ensuring they follow specific guidelines to protect confidential information.

The Food and Drug Administration (FDA) announced the user fee rates for fiscal year 2025 under the Over-the-Counter (OTC) Monograph Drug User Fee Program. This program allows the FDA to collect fees from manufacturers of OTC monograph drugs, which do not require a new drug application. For FY 2025, the fee for facilities manufacturing these drugs is set at $37,556 for monograph drug facilities and $25,037 for contract manufacturing organizations. These fees help the FDA cover the costs associated with regulating OTC monograph drugs.

The Food and Drug Administration (FDA) has announced the availability of draft guidance for devices that use artificial intelligence (AI)-enabled software functions. This draft guidance, once finalized, will give recommendations for what should be included in marketing submissions, focusing on safety and effectiveness. It suggests a total product lifecycle (TPLC) approach, which considers the design, development, and implementation stages of AI-enabled devices. Public comments on this draft are sought to ensure that FDA’s guidance aligns with the fast-evolving field of AI and adequately addresses performance and risk concerns.

The Food and Drug Administration (FDA) has withdrawn a previous notice regarding the debarment of Yong Sheng Jiao, which was published on December 5, 2024. The initial notice contained incorrect information about the reasons for debarment and left out revised language. A corrected version of the notice will be published separately in the same edition of the Federal Register. This action was taken to ensure the accuracy of the official record.

The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

The Food and Drug Administration (FDA) announced a correction to a previous notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs). These applications, held by companies like Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, were initially set to be withdrawn by August 28, 2024. However, because these companies asked in time not to have their ANDAs withdrawn, the approvals remain valid. This notice clarifies the error and ensures the continued approval of these drug applications.

The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget for review under the Paperwork Reduction Act. This collection involves the De Novo classification process, which evaluates if a medical device can be classified as class I or II, assuring its safety and effectiveness in the absence of a similar marketed device. The process includes regulatory guidelines and electronic submission templates. Feedback on the proposal is welcomed until January 29, 2025, via the OMB's online portal.