Search Results for keywords:"public health emergency"

The Food and Drug Administration (FDA) has made available a final guidance document titled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates a previous version and includes a list known as the 506J Device List, which outlines device product codes that manufacturers must notify the FDA about if they stop production. The document clarifies that manufacturers can also voluntarily notify the FDA of any supply chain issues, regardless of public health emergencies. This guidance aims to facilitate continuous device supply and prevent shortages.

The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

In January 2021, the Department of Homeland Security (DHS) and the Department of Justice (DOJ) decided to delay the effective date of a rule concerning the eligibility for asylum and withholding of removal due to potential security risks relating to public health emergencies. This delay, lasting 60 days from January 21 to March 22, 2021, came after a memorandum from the White House Chief of Staff suggested pausing pending regulations for review. The delay was also necessary because of a preliminary court injunction against a related rule that could affect the implementation of this new rule.

The Food and Drug Administration (FDA) released new guidelines for testing alcohols like ethanol and isopropyl alcohol for methanol contamination, especially during the COVID-19 pandemic. The guidance alerts pharmaceutical manufacturers and pharmacists about the dangers of using methanol-contaminated alcohols in drug products, which can pose significant health risks. Due to the urgent health emergency, these guidelines were issued without prior public comment and are immediately effective, although they can still receive comments for future updates. The guidance aims to ensure the safe use of pharmaceutical alcohol by focusing on proper identity testing and supply chain oversight.

The Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUAs) for biological products during the COVID-19 pandemic, one requested by Pfizer, Inc., and the other by ModernaTX, Inc. These Authorizations allow the use of vaccines to help manage the public health emergency declared by the Secretary of Health and Human Services. The Authorizations include specific conditions and are part of efforts to protect public health and national security in response to the SARS-CoV-2 virus, which causes COVID-19. The FDA ensures that such products can be used when there are no adequate, approved alternatives available.

The U.S. Nuclear Regulatory Commission (NRC) has issued five exemptions for licensees in response to challenges posed by the COVID-19 public health emergency. These exemptions provide temporary relief from specific regulatory requirements to help facilities maintain safe operations and manage worker fatigue and security during the pandemic. The exemptions apply to parts of the regulation concerning work-hour controls and security personnel training and qualifications. Details about these exemptions and corresponding documentation can be accessed through various methods described in the notice.

The Food and Drug Administration (FDA) announced the availability of guidance documents related to the COVID-19 public health emergency. The guidance has been released without prior public comment to expedite the response to the pandemic but remains open for public input. Electronic or paper comments on these documents can be submitted through designated channels. These guidelines reflect the FDA's current practices and do not impose any binding obligations but serve as recommendations for the industry and relevant stakeholders.

The Food and Drug Administration (FDA) has released draft guidance on how in vitro diagnostic devices (IVDs) should be validated during emergencies involving emerging pathogens, declared under Section 564. This guidance is currently in draft form and not yet ready for implementation. It gives general recommendations for testing devices to ensure they are accurate and reliable during health crises like disease outbreaks. The FDA encourages public comments on the draft by March 10, 2025, either electronically or by mail, before finalizing the guidance.

The National Institute of Allergy and Infectious Diseases (NIAID) is offering royalty-free access to a specially developed starting material, known as "MVA clone-1," for creating and commercializing a vaccine against mpox. This initiative aims to improve vaccine access, especially in underserved regions, and respond to a 2024 public health emergency called by the World Health Organization due to a significant outbreak in the Democratic Republic of the Congo. Interested parties with solid plans to develop and distribute the vaccine in high-need areas can collaborate with NIAID. The material shows promise as it is similar to an already approved vaccine and has been shown to protect against mpox in both normal and at-risk populations.

The Occupational Safety and Health Administration (OSHA) has decided to end its rulemaking process concerning COVID-19 exposure in healthcare settings. Originally, OSHA issued an Emergency Temporary Standard (ETS) in 2021 to protect healthcare workers from COVID-19, but with the COVID-19 public health emergency over, OSHA believes a standard focusing on broader infectious diseases is more appropriate for long-term worker protection. Instead of finalizing a separate COVID-19 regulation, OSHA will concentrate resources on creating comprehensive rules addressing various infectious diseases, including COVID-19, to better safeguard healthcare workers.