Food And Drug Administration | sciencenewsnet.in

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

March 6, 2020 sarah Jonas Aacc, american association for clinical chemistry, coronavirus testing, Diagnostic Testing, FDA Regulations, Food And Drug Administration

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.

Policy

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

March 2, 2020 sarah Jonas Aacc, american association for clinical chemistry, Coronavirus, coronavirus disease 2019, COVID-19, Diagnostic Testing, FDA, FDA Regulations, Food And Drug Administration

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.

Research Results

Researchers Show How Ebola Virus Hijacks Host Lipids

February 15, 2020 sarah Jonas Biophysical Society, Biophysical Society 64th Annual Meeting, Biophysical Society Annual Meeting, BPS, BPS20, Ebola, Ebola Virus, FDA, Food And Drug Administration, Lipids

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.

Announcement

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

January 28, 2020 sarah Jonas 0 Comments Food And Drug Administration, HEOR, ISPOR, Medical Device, Medical Devices

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.

Policy

ASTRO applauds Senate confirmation of Dr. Stephen Hahn as U.S. Food and Drug Administration Commissioner

December 12, 2019 sarah Jonas 0 Comments FDA, Food & Drug Administration, Food And Drug Administration, Hahn

The American Society for Radiation Oncology (ASTRO) applauded the U.S. Senate for voting today to confirm radiation oncologist Stephen Hahn, MD, FASTRO, as the next Commissioner of the Food and Drug Administration (FDA).

Announcement

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

November 14, 2019 sarah Jonas 0 Comments FDA, Food And Drug Administration

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.

Feature

The E-cigarette Backlash

October 9, 2019 sarah Jonas 0 Comments China, e-cigarette, Food And Drug Administration, Health, Health Policy, India, Nicotine, Public Health, United States, Vapor

CFR In Brief by Claire Felter. An outbreak of a lung illness linked to vaping is raising the pressure on countries to rein in the booming e-cigarette industry.