Search Results for keywords:"Safety Issues"

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Search Results: keywords:"Safety Issues"

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  • 2021-03541 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
    Type:Notice
    Citation:86 FR 10975
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) is inviting public comments on its proposed information collection related to adverse experience reporting for licensed biological products. This reporting is crucial for identifying serious safety issues with these products after they have been marketed. The FDA requires that manufacturers report adverse experiences quickly and periodically, and also maintain detailed records for a certain number of years. Public comments can be submitted through the designated OMB website by March 25, 2021.

    Simple Explanation

    The FDA wants to hear from people about how they collect important safety information on certain medicines, which helps keep people safe after the medicines are sold. They are asking for comments and want to know what people think before March 25, 2021.

  • 2025-03355 — Implementing the Whistleblower Provisions of the Vehicle Safety Act
    Type:Rule
    Citation:90 FR 11029
    Reading Time:about 3 minutes

    The National Highway Traffic Safety Administration (NHTSA), part of the U.S. Department of Transportation, announced it will not enforce the rules of the "Implementing the Whistleblower Provisions of the Vehicle Safety Act" until March 20, 2025. This decision allows more time for the new administration to review the rule and ensure it aligns with their policies. The whistleblower provisions aim to award individuals who provide significant information about vehicle safety issues that result in legal actions. The enforcement delay follows a broader regulatory review directive issued by the President.

    Simple Explanation

    The people who make rules about car safety say they won't start using a new rule that helps people tell secrets about car problems until March 2025. They need more time to check if everything is okay with the new rule.