Tag: Food And Drug Administration

ACI Urges FDA to Address Hand Sanitizer Safety Concerns

sarah JonasPolicy

The American Cleaning Institute (ACI) is pressing the U.S. Food and Drug Administration (FDA) to clarify policies on labeling and refilling practices involving hand sanitizers.

In a letter sent to the agency, ACI expressed concerns related to the “new, increasingly widespread practice of providing hand sanitizers to consumers in public settings…that are often sold in bulk and used to fill existing dispensers, which can create a serious risk to public health and safety.”

AACI Applauds Approval of COVID-19 Vaccine, Supports Widespread Vaccination Efforts

sarah JonasPolicy

The Association of American Cancer Institutes (AACI) commends the U.S. Food and Drug Administration (FDA) for its swift action to grant Emergency Use Authorization (EUA) to Pfizer’s COVID-19 vaccine.

UCLA, UCSF gain FDA approval for prostate cancer imaging technique

sarah JonasFeature

The University of California’s two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated.

Rapid disease pathogen identification a step closer following successful UAH startup demonstration

sarah JonasFeature

Soon it could only take an hour to find out what pathogen is making you ill, following the successful demonstration of the world’s first multi-pathogen identification using non-amplified RNA detection by GeneCapture, a company cofounded by researchers at The University of Alabama in Huntsville (UAH).

NCCN Policy Summit Explores 21st Century Cures Act and the Impact of Health Information Technology

sarah JonasFeature

Online summit from NCCN on 21st Century Cures Act includes bipartisan sponsors, regulatory authorities; examines the impact on and from COVID-19 on cancer care and technology; presents policy recommendations for using data to advance patient access to high-quality cancer care

New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing

sarah JonasPolicy

On March 5, U.S. House and Senate lawmakers introduced the VALID Act, which would give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests—tests that are already regulated by the Centers for Medicare and Medicaid Services (CMS) and are subject to stringent personnel, quality control, and proficiency testing requirements. This bill promotes duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests. AACC urges Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.

AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

sarah JonasPolicy

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.

Researchers Show How Ebola Virus Hijacks Host Lipids

sarah JonasResearch Results

Robert Stahelin studies some of the world’s deadliest viruses. Filoviruses, including Ebola virus and Marburg virus, cause viral hemorrhagic fever with high fatality rates. Stahelin, professor at Purdue University, examines how these viruses take advantage of human host cells.

ISPOR-FDA Summit 2020 Will Focus on the Use of Patient-Preference Information in Medical Devices

sarah JonasAnnouncement

ISPOR—the professional society for health economics and outcomes research, announced that it will be holding a joint ISPOR-FDA Summit, “Using Patient-Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond,” on March 31, 2020 in Silver Spring, MD, USA.

FDA awards $1.7 million to IU and other universities for quality management research

sarah JonasAnnouncement

The U.S. Food and Drug Administration has awarded $1.7 million to five universities, including Indiana University, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.