A sine qua non for drug approval by the US Food and Drug Administration (FDA) is demonstrated efficacy in populations of patients. However, it is virtually axiomatic that individuals vary in their responses to drugs. Work over decades has built a knowledge base that describes the role of genetic variation as a modulator of both drug efficacy and rare adverse drug effects.1 This increasing under...

Background: The use of a neutropenic diet after hematopoietic stem cell transplantation (HSCT) was instituted more than 30 years ago. This diet was targeted toward preventing from infection with organisms colonizing the gastrointestinal tract and the food-borne pathogens, which are the most important cause of illness and death in developing countries. Regarding this, the present study aimed to ...

Poly(lactic-co-glycolic) acid (PLGA) has attracted a considerable amount of interest for biomedical application due to its biocompatibility, tailored biodegradation rate (depending on the molecular weight and copolymer ratio), approval for clinical use in humans by the U.S. Food and Drug Administration (FDA), the potential to change surface properties to create better interaction with biologica...

A dizzying array of chemical compounds is used in modern food. Artificially manufactured dyes, preservatives, flavors, texture enhancers, and fats enhance the way food looks, tastes, and feels. Considerable debate has raged over the long-term safety of chemical food additives, which are regulated by the Food and Drug Administration (FDA) in the United States. The FDA allows the addition of non-...

In 2012, CDC collaborated with state health and agricultural agencies and the Food and Drug Administration (FDA) to investigate an outbreak of Salmonella Bredeney infections associated with exposure to peanut products manufactured by Sunland, Inc. of Portales, New Mexico.

COMMERCIAL MEDICARE & MEDICAID COVERAGE RATIONALE .......................................... 1 DESCRIPTION OF SERVICES .............................................................................................................. 4 CLINICAL EVIDENCE ........................................................................................................................... 5 U.S. FOOD AND DRUG AD...

Imiquimod 5% is a drug approved by the US Food and Drug Administration (FDA) for the topical treatment of genital warts, actinic keratosis, and basal cell carcinoma (BCC). While this drug is commonly used in daily clinical practice, no reports to date have associated its administration with alterations in scar formation. We describe 2 cases of abnormal scar formation after treatment with imiqui...

The US Food and Drug Administration (FDA) expanded access pathway allows patients with life-threatening or serious conditions to investigational drugs outside of trials, under certain conditions. 21st Century Cures Act (“Cures Act”) requires drug companies publicly disclose their policies. We characterized the proportion applicable biopharmaceutical companies, an oncology related drug, implemen...

Consumers increasingly use online pharmacies. However, illicit pharmacies endanger consumer welfare with unapproved and counterfeit drugs. By linking Food Drug Administration (FDA) warning letter content observations of the 1108 websites cited in those letters, we identify factors associated FDA-requested compliance active/inactive website status. One five failed to comply FDA recommendations. ...

COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE ......................................... 1 DESCRIPTION OF SERVICES .............................................................................................................. 2 CLINICAL EVIDENCE ........................................................................................................................... 2 U.S. FOOD AND DRUG AD...