In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidat...

The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for...

Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration ...

Abstract As more information about the potential risks and complications related to breast implants has become available, United States Food Drug Administration (FDA) responded by implementing changes improve patient education, recalling certain devices updating recommendations for screening silicone implant rupture. In addition staying up-to-date with FDA actions guidance, radiologists need ma...

Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature search...

Our study aimed to assess inequities in the clinical trial participation for selected patient groups. We searched Food and Drug Administration (FDA) database extracted phase-III data from MEDLINE each approved drug by FDA between January 1, 2006, June 30, 2020. analyzed inclusion/exclusion criteria, according gender, ethnic group, performance score, positivity of HBV HCV, HIV, having comorbidit...

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October...

OBJECTIVE The US Food and Drug Administration (FDA) proposes to establish standardized and mandatory criteria upon which front-of-pack (FOP) nutrition labelling must be based. The present study aimed to estimate the relative contribution of declared amounts of different nutrients to the perception of the overall 'healthfulness' of foods by the consumer. DESIGN Protein, fibre, vitamin A, vitam...

BACKGROUND Antidepressant-induced extrapyramidal symptoms (EPS) represent an underrecognized but important clinical entity. We reviewed the literature on new antidepressants and conducted an analysis of cases from the FDA Adverse Event Reporting System (AERS), which has not been published before. METHODS A literature review was conducted using PubMed, Ovid, MEDLINE, PsycINFO, and the Cochrane...