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The Food and Drug Administration (FDA) announced that certain drug products, including Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, have not been taken off the market for safety or effectiveness issues. This means that generic versions of these drugs can still be approved by the FDA and sold, as long as they follow the necessary legal and regulatory guidelines. The drugs will be listed in the "Discontinued Drug Product List" in the Orange Book because they are no longer being sold, but not for reasons related to safety or effectiveness.

The Food and Drug Administration (FDA) has released draft guidance to accelerate the approval process for drugs and biologics meant for serious or life-threatening conditions. This expedited program aims to quickly develop and review drugs that address unmet medical needs. The draft outlines the criteria for accelerated approval, including surrogate endpoints and confirmatory trials, and introduces procedures for rapidly withdrawing approvals if necessary. The public can submit comments on this draft by February 4, 2025, and share thoughts on the expedited withdrawal procedures and other aspects of the accelerated approval process.

The Food and Drug Administration (FDA) has released a notice regarding updates to the list of standards used in assessing medical devices, known as the "FDA Recognized Consensus Standards." These updates, called "Recognition List Number: 063," help manufacturers who wish to align their products with these standards. People can submit comments or suggestions for additional standards anytime, and the FDA keeps a database of the recognized standards available online. The updated list of standards is effective from March 20, 2025.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is proposing a rule that would require alcohol beverage labels to disclose the presence of major food allergens such as milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, and sesame. This initiative aims to give consumers who are allergic to these foods essential information to make informed choices about alcohol consumption. The proposal is part of a broader push to standardize labeling with other food products, and TTB is considering an extended compliance period to reduce the impact on the industry, particularly small businesses. Comments on the proposal are being sought until April 17, 2025.

The Food and Drug Administration (FDA) is seeking public feedback on a proposed information collection related to the regulation of blood and blood components. This initiative, required by the Paperwork Reduction Act of 1995, involves guidelines for good manufacturing practices, donation testing, donor notification, and procedures for tracking potentially tainted blood ("lookback"). The FDA is interested in comments on the necessity and usefulness of the data collection, the accuracy of its burden estimates, and potential improvements to reduce respondent burdens. Stakeholders have until April 23, 2021, to submit their responses to the proposal.

The Food and Drug Administration (FDA) determined that MOBIC (meloxicam) tablets, available in 7.5 mg and 15 mg doses, were not withdrawn from sale because of safety or effectiveness concerns. This means that the FDA will continue to approve generic versions of this medicine as long as they meet all legal and regulatory requirements. MOBIC is used to treat arthritis symptoms and is now listed in the "Discontinued Drug Product List," but this listing does not imply any safety issues. The FDA will ensure that any needed updates to the drug's labeling are made.

The Food and Drug Administration (FDA) announced that ETHYOL (amifostine) for injection, 500 mg/vial, was not removed from the market due to safety or effectiveness issues. This ruling implies that the FDA will not take action to revoke approvals for generic versions of this drug and can continue approving such versions if they comply with legal standards. The determination follows a petition and a review of available data, with no evidence found suggesting safety problems. As such, ETHYOL will stay on the "Discontinued Drug Product List" for reasons unrelated to safety or effectiveness.

The Food and Drug Administration (FDA) has determined that the drug VIBRAMYCIN (doxycycline) for oral suspension was not taken off the market due to safety or effectiveness concerns. This decision allows the FDA to continue approving generic versions of this medication as long as they meet legal and regulatory criteria. VIBRAMYCIN is included in the “Discontinued Drug Product List” because it was removed from sale for reasons unrelated to safety or effectiveness. If necessary, the FDA may require updates to the drug’s labeling to align with current standards.

The Food and Drug Administration (FDA) is proposing a new rule to set a maximum nicotine level in cigarettes and other combusted tobacco products. This measure aims to decrease the addictiveness of these products, making it easier for people who want to quit to do so, and to prevent youth from becoming addicted. The rule is expected to benefit public health by reducing the number of individuals who start smoking or continue smoking over time. The proposal could potentially improve health outcomes by reducing the overall harmful effects of tobacco addiction.

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.