Search Results for keywords:"FDA"

The Food and Drug Administration (FDA) is announcing a public advisory committee meeting for the Cellular, Tissue, and Gene Therapies Advisory Committee on April 15, 2021. This meeting, which will be held online due to the COVID-19 pandemic, aims to discuss scientific issues such as biologics license applications. The public can submit comments electronically or on paper until April 14, 2021. The FDA encourages public participation and will provide online access to the meeting materials two days before the event.

The Food and Drug Administration (FDA) has decided that the drug NYMALIZE (nimodipine), oral solution at a strength of 3 mg/mL, was not taken off the market for safety or effectiveness reasons. This decision enables the approval of generic versions of this drug, provided they meet other requirements. Although the 3 mg/mL version was discontinued, the FDA believes it would still be safe and effective if sold today, but suggests making some labeling changes to prevent confusion with another version that is 6 mg/mL.

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has delayed the effective date of a rule regarding nonprescription drug products with an additional condition for nonprescription use (ACNU). Originally set to take effect on January 27, 2025, the rule is postponed to March 21, 2025, due to a memorandum from the President calling for a "Regulatory Freeze Pending Review." This delay is intended to allow further examination of the rule and its implications, ensuring it aligns with legal and policy considerations. The rule outlines requirements for nonprescription drugs involving applications, labeling, and postmarketing reporting, differentiating them from prescription drugs based on these additional conditions.

The Food and Drug Administration (FDA) is issuing a permanent debarment order against Joseph A. Rowan, preventing him from working with any businesses that have drug product applications. This order results from Mr. Rowan's felony conviction related to illegal activities with the drug SUBSYS while at Insys Therapeutics. He was found guilty of racketeering, mail fraud, and wire fraud, including bribing doctors to prescribe SUBSYS to patients without cancer and misleading insurers. Mr. Rowan was notified of this debarment decision and waived his right to contest it by not requesting a hearing.

The Food and Drug Administration (FDA) is withdrawing the approval of 27 abbreviated new drug applications because the companies that made these drugs told the FDA that they are no longer selling them. The withdrawal means these drugs will no longer have permission to be sold in the market. This action will take effect on February 16, 2021, but any remaining drug inventory that is still compliant with regulations can be used up until it runs out or expires.

The Food and Drug Administration (FDA) is asking for public comments on gathering information related to food additives for animal food. Under the Paperwork Reduction Act, federal agencies must allow 60 days for public comments on such collections. The FDA is revising its information collection efforts to include new guidance related to the safety of pet food under recent amendments. They also explain the estimated time and effort it takes for companies to submit necessary documentation and consult with the FDA on animal food additives.

The Food and Drug Administration (FDA) announced the availability of its annual update on the Susceptibility Test Interpretive Criteria web page, part of procedures under the 21st Century Cures Act. This web page lists standards used to determine the effectiveness of antimicrobial drugs, making it easier for device makers to update their testing products. The FDA is requesting public comments and will update the standards based on feedback. The agency recognizes new standards and withdraws others, such as ones from the Clinical and Laboratory Standards Institute, as part of this ongoing update process.

The Food and Drug Administration (FDA) is asking for public feedback on gathering certain data about reprocessed, single-use medical devices under the Paperwork Reduction Act. This public comment period lasts for 60 days, ending on April 26, 2021. The FDA wants to know if the information collection is necessary, how accurate their burden estimates are, and if there are better ways to collect data. This initiative aims to ensure that reprocessed devices clearly show the manufacturer's name or symbol to prevent misbranding, as required by federal law.

The Food and Drug Administration (FDA) is updating the definition of the term "healthy" as it applies to food labeling to align with current nutrition science and dietary guidelines. This new rule outlines what food manufacturers must meet to label their products as "healthy," focusing on food groups and limiting certain nutrients like added sugars, saturated fats, and sodium. The rule aims to help consumers make better choices for maintaining a nutritious diet and to reduce diet-related chronic diseases. It is designed to ensure that foods labeled as "healthy" provide accurate and helpful information, promoting overall health and nutrition equity.

The Food and Drug Administration (FDA) has released a draft guidance document titled "Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies." This document aims to promote the inclusion and analysis of sex- and gender-specific data in medical device studies to ensure safety and effectiveness. Historically, females and nonbinary individuals have been underrepresented in clinical trials, leading to inadequate information about medical devices for these groups. The guidance encourages sponsors to incorporate diverse data in clinical studies and reporting, but it is currently not final and the public is invited to submit comments until April 7, 2025.