Infection Prevention Highlights from the FDA’s Rare Disease Day 2026: Urgency and Flexibility Drive Rare Disease Development

Industry leaders came together on a shared platform at the FDA’s Rare Disease Day 2026 to discuss the novelty of the regulatory pathways, swifter review programs, and patient-centric innovations that contribute to the rapid development of treatments for rare diseases. The primary focus was on diseases such as NF1 and pediatric cancers. The key takeaway…

February 27, 2026

Infection Prevention News

Inadequate Staffing Increases Infection Rates while Breakthrough Research and Medical Devices Offer Hope: A Glimpse at Recent Medical Developments

In a world that often stresses the importance of quality healthcare, new studies are reminding us of the role adequate staffing plays in this equation. In a report published in the American Journal of Infection Control, an alarming correlation has been identified; hospitals that are understaffed often report high rates of healthcare-associated infections such as…

October 22, 2024

Infection Prevention News

FDA Grants Enforcement Discretion for Conjunctival Swabs Use in H5N1 Bird Flu Testing Amid Rising Cases

The Food and Drug Administration (FDA) has recently granted enforcement discretion for the use of conjunctival swabs in human testing for the H5N1 bird flu. This decision came on the heels of two human cases where conjunctivitis was the only symptom observed before the H5N1 infection was confirmed. The Centers for Disease Control and Prevention…

June 6, 2024

Infection Prevention News

Navigating the FDA’s Revised Authorization and Ensuring a Seamless Transition from Emergency-Use-Labeled Paxlovid to Approved Labeling

In December 2021, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for Pfizer's novel antiviral drug Paxlovid, ushering in a new tool for managing severe COVID-19 cases in individuals with a high risk of serious illness. By May 2023, the FDA had further validated Paxlovid's efficacy by approving its new…

February 1, 2024

Infection Prevention News

FDA Announces Changes to Emergency Use Label for Paxlovid

In a significant update for healthcare providers engaged in the fight against COVID-19, the Food and Drug Administration (FDA) has pronounced that Paxlovid, a therapeutic drug developed by Pfizer, may no longer be distributed under an emergency use label post March 8. According to the new guidelines, providers may continue to dispense any leftover Paxlovid…

January 31, 2024

Infection Prevention News

FDA’s Updated Sterilization Guidance: A New Perspective on 510(k) Submissions for Sterile Devices

Positioned in Silver Spring, Maryland, USA, the United States Food and Drug Administration (FDA) headquarters stand as a beacon of regulatory oversight. The organization is taking solid steps towards reshaping the medical device sterilization landscape with the recent release of its definitive guidance on essential inclusion factors for sterile device 510(k) submissions. This guidance, solemnly…

January 24, 2024

Infection Prevention Highlights from the FDA’s Rare Disease Day 2026: Urgency and Flexibility Drive Rare Disease Development

Inadequate Staffing Increases Infection Rates while Breakthrough Research and Medical Devices Offer Hope: A Glimpse at Recent Medical Developments

FDA Grants Enforcement Discretion for Conjunctival Swabs Use in H5N1 Bird Flu Testing Amid Rising Cases

Navigating the FDA’s Revised Authorization and Ensuring a Seamless Transition from Emergency-Use-Labeled Paxlovid to Approved Labeling

FDA Announces Changes to Emergency Use Label for Paxlovid

FDA’s Updated Sterilization Guidance: A New Perspective on 510(k) Submissions for Sterile Devices

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