This study describes audiologic methodology and results for evaluating potential ototoxicity in a phase I clinical trial of a new glycopeptide. This study was conducted under good clinical practices, which are regulated by the US Food and Drug Administration (FDA) (21 Code of Federal Regulations), and input from the FDA was sought prior to study implementation. Healthy, normal volunteers underw...

System accuracy requirements for blood glucose (BG) meters (BGMs) are defined in standards (1) or guidance documents (2). In 2013, International Organization for Standardization (ISO) 15197:2013 stated that BGMs are acceptably accurate if $95% of their measurement results are found within 615 mg/dL (0.83 mmol/L) or 615% (whichever is larger) of reference results (1). The 2014 U.S. Food and Drug...

Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirem...

On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs. The proposals come at a time when FDA has found itself under new pressure to provide seriously ill patients with early access to investigational ...

The American Association of Bioanalysts (AAB) a national professional association whose members are directors, owners, managers, and supervisors of community clinical laboratories respectfully submits the following comments relating to the Food and Drug Administration’s (FDA) medical devices draft guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) criteria for waiver. AAB me...

n 1958, Congress enacted the Food Additives Amendment (FAA) to the Federal Food, Drug, and Cosmetics Act amid growing concern over the safety of substances added to foods. The FAA set forth standards and guidelines by which the safety of food additives must be established before they can be added to foods (FAA, 1958). The FAA contained an exclusion provided by Congress for substances “generally...

OBJECTIVE To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. DESIGN Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sp...

Microring-based photonic fractional differentiators play an important role in the on-chip all-optical signal processing. Unfortunately, the previous works do not consider the time-reversal and the time delay characteristics of the microring-based fractional differentiator. They also do not include the effect of input pulse width on the output. In particular, it cannot explain why the microring-...

Background: Convalescent plasma therapy is the only antibody-based used to treat COVID-19 Patients. The use of convalescent has been recommended by Food and Drug Administration (FDA) as a for patients (FDA in Asep, 2020). Several routine biomarker parameters indicators diagnosis are CRP, IL-6 D-Dimer. There was change between three values IL-6, D-Dimer on who did not receive therapy. This revie...