Search Results for keywords:"effectiveness"

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Search Results: keywords:"effectiveness"

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  • 2025-06044 — Determination That ETHYOL (Amifostine) for Injection, 500 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 15248
    Reading Time:about 3 minutes

    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.

    Simple Explanation

    The FDA decided that a medicine called ETHYOL, which is used to protect the body during cancer treatment, was not taken off the shelves because it is unsafe or doesn't work. This means other companies can still make and sell generic versions of it.

  • 2025-01979 — General Services Administration Acquisition Regulation (GSAR); Update to OMB Approval Table
    Type:Rule
    Citation:90 FR 8682
    Reading Time:about a minute or two

    The General Services Administration (GSA) is delaying the start of certain regulation changes, which were initially published on December 27, 2024, and planned to take effect in January 2025. This 60-day postponement ensures compliance with a Presidential Memorandum issued by President Donald J. Trump, which called for a regulatory freeze pending review. The regulation updates will now become effective on March 27, 2025.

    Simple Explanation

    The government agency in charge of managing buildings and supplies has decided to wait a little longer before changing some rules that they were going to start using soon, because the President asked to hold off and take another look before making any changes.

  • 2025-04020 — Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 11991
    Reading Time:about 3 minutes

    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.

    Simple Explanation

    The FDA says that a type of liquid medicine called RIOMET, which helps control blood sugar, was not taken off shelves because it was dangerous or didn't work. This means that other companies can make and sell this medicine too, as long as they follow the rules.