Search Results for keywords:"section 529 FD

The Food and Drug Administration (FDA) confirmed that RIOMET, a metformin hydrochloride oral solution, was not taken off the market for safety or effectiveness issues. This finding means that the FDA can continue approving generic versions of this medication if they meet legal requirements. RIOMET is listed as discontinued in the FDA's "Orange Book," but this is not due to any safety concerns. As a result, companies can still seek approval to produce generic versions of RIOMET, provided they comply with all necessary regulations.

The Food and Drug Administration (FDA) has determined that NASCOBAL, a nasal spray containing 0.5 mg of cyanocobalamin (vitamin B12), was not removed from the market due to safety or effectiveness concerns. This decision means that the FDA will continue to approve generic versions of NASCOBAL as long as they meet all legal and regulatory requirements. The drug remains listed in the "Discontinued Drug Product List" section of the Orange Book, which indicates it was not discontinued for safety reasons. If needed, the FDA will instruct generic drug makers to update their labeling to current standards.

The Food and Drug Administration (FDA) has determined that DECADRON, a medication with the active ingredient dexamethasone sodium phosphate, was not taken off the market for reasons related to safety or effectiveness. This decision allows continued approval of generic versions of the drug as long as they comply with necessary legal and regulatory standards. DECADRON will remain on the "Discontinued Drug Product List," which includes drugs discontinued for reasons other than safety or effectiveness. The FDA reviewed data and found no evidence of safety concerns leading to the drug's withdrawal.

The Food and Drug Administration (FDA) has determined that the drug FLUMADINE (rimantadine hydrochloride) 100 mg tablets were not taken off the market due to safety or effectiveness concerns. As a result, the FDA will not start withdrawing approval for generic versions of this drug, and it may continue approving them if they meet legal standards. FLUMADINE was originally approved in 1993 for treating and preventing influenza A in adults and for prevention in children. Despite being discontinued by the manufacturer, it remains listed in the Orange Book as discontinued for reasons other than safety or effectiveness.

The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection concerning class II special controls for automated blood cell separator devices. This notice, published under the Paperwork Reduction Act of 1995, requires federal agencies to notify the public about proposed information collections and give them 60 days to respond. The FDA is inviting feedback on the utility of the information collection, its accuracy, and suggestions for enhancing its clarity and minimizing the burden on respondents. Comments can be submitted electronically or in writing until April 19, 2021.

The Department of Health and Human Services (HHS) has extended a designation from July 2020 that identifies certain health and medical resources as scarce or threatened due to potential hoarding during the COVID-19 pandemic. This includes items like hypodermic needles and syringes, along with personal protective equipment and ventilators, which are essential for managing the virus's spread. The extension, effective from February 1, 2021, through June 30, 2021, aims to ensure these resources are distributed properly and not accumulated excessively by individuals or entities not in need. The extension also includes some modifications to the list of designated resources.

The Food and Drug Administration (FDA) has updated regulations to reflect the withdrawal of approval for seven new animal drug applications due to non-compliance with reporting requirements. This change means that certain firms are no longer recognized as sponsors for these drugs. The decision takes effect on February 23, 2021, and involves technical amendments to various parts of the Code of Federal Regulations to ensure accuracy. The rule does not impose any new burdens on businesses and is not subject to further review or certain regulatory requirements.

The Food and Drug Administration (FDA) is seeking public comments on a proposed collection of information as part of its requirement for the Office of Management and Budget (OMB) review under the Paperwork Reduction Act of 1995. This initiative pertains to the application process for FDA approval to market new drugs, covering the submission of data and patent details as specified in FDA regulations. The FDA has developed specific forms to aid applicants and has made updates to the process to improve efficiency. Public comments on these proposals are welcomed by March 18, 2021.

The Food and Drug Administration (FDA) is seeking public feedback on a proposed information collection regarding prescription drug labeling. This information is being reviewed by the Office of Management and Budget (OMB) as required by the Paperwork Reduction Act. The proposal primarily concerns updating and revising regulations for drug labeling, including safety labeling changes and medical gas container labeling. The FDA is inviting comments until March 5, 2025, and offers guidance for companies required to comply with these labeling standards.

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.