💊FDA Report on Drug Firms' Postmarketing Requirements and Commitments
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https://www.fda.gov/drugs/postmarketing- requirements-and-commitments-introduction/postmarketing-requirements- and-commitments-reports).
Learn More🚌NHTSA Proposes to Remove Obsolete School Bus Safety Requirements
NHTSA is proposing to remove obsolete requirements from Federal Motor Vehicle Safety Standard (FMVSS) No. 222, "School bus passenger seating and crash protection."
Learn More🚫FDA Withdraws Approval of Two Drug Applications - Business Implications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two new drug applications (NDAs) from two applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More✈️FAA Notice
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Learn More⛽Proposed Changes to Fuel Tank Overfill Regulations by FMCSA
FMCSA proposes to remove the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that a liquid fuel tank manufactured on or after January 1, 1973, be designed and constructed so that it cannot be filled, in a normal filling operation, with a quantity of fuel that exceeds 95 percent of the tank's liquid capacity. This proposal is in response to a petition for rulemaking from the Commercial Vehicle Safety Alliance (CVSA). The proposed change would remove an unnecessary and outdated requirement from the FMCSRs.
Learn More🚗Proposed Rule on Federal Motor Vehicle Safety Standards No. 303
NHTSA is proposing to remove obsolete directives from the phase-in reporting requirements for Federal Motor Vehicle Safety Standard (FMVSS) No. 303.
Learn More🚗NHTSA Proposes Removal of Obsolete Vehicle Safety Requirements
NHTSA is proposing to remove obsolete requirements from Federal Motor Vehicle Safety Standard (FMVSS) No. 206, "Door locks and door retention components."
Learn More🚚FMCSA Repeals Obsolete Motor Carrier Routing Regulations
FMCSA repeals the for-hire motor carrier routing regulations which concern servicing municipalities and unincorporated communities. These regulations are unlawful because they exceed FMCSA's statutory authority following the transfer of rules from the Interstate Commerce Commission (ICC) to the Federal Highway Administration (FHWA) in 1995, which were carried over to FMCSA in 2000.
Learn More⚡Notice of Filing for Interlocking Positions by FERC
The Department of Energy published a notice regarding Christopher F. Cosby's application to hold interlocking positions under the Federal Power Act. The notice outlines procedures for public intervention and protest, encourages electronic filings, and provides resources for public participation. Interested individuals are invited to engage with the filing process before the comment date.
Learn More🚫FDA Issues 5-Year Debarment Order Against Evan Asher Field
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Evan Asher Field for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Field was convicted of one felony count under Federal law. The factual basis supporting Mr. Field's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Field was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of April 25, 2024 (30 days after receipt of the notice), Mr. Field had not responded. Mr. Field's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
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