Rosemary A M Roberts

Learn More
CONTEXT Approximately 50% to 75% of drugs used in pediatric medicine have not been studied adequately to provide appropriate labeling information. In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA), which encouraged pediatric drug development by providing an incentive in the form of additional marketing exclusivity. (More)
OBJECTIVE The goal was to review the impact of pediatric drug studies, as measured by the improvement in pediatric dosing and other pertinent information captured in the drug labeling. METHODS We reviewed the pediatric studies for 108 products submitted (July 1998 through October 2005) in response to a Food and Drug Administration written request for(More)
CONTEXT Much of pediatric drug use is off-label because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children. In 1997, Congress authorized the FDA to grant extensions of marketing rights known as "pediatric exclusivity" if FDA-requested pediatric trials(More)
OBJECTIVE To give academic researchers, government officials, and industry scientists an opportunity to assess the state of pediatric psychopharmacology and identify challenges facing professionals in the field. METHOD Increased federal spending and the introduction of pediatric exclusivity led to large increases in pediatric psychopharmacology research(More)
A prominently displayed boxed warning, the so-called "black box," is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and(More)
As part of a consensus conference on cesarean birth, the ten-member consensus panel rated 224 clinical scenarios on their appropriateness for a cesarean section. Ratings were obtained before and immediately after the consensus conference. The level of agreement (consensus) among panelists was assessed separately for scenarios with good research evidence(More)
The mission of the US Food and Drug Administration (FDA) is to protect public health by ensuring the safety, efficacy, and quality of drugs. In drug development, animal studies play a key role in assessing the safety (toxicology), pharmacokinetics (PK), and proof-of-concept efficacy of a new product. When clinical studies are neither ethical nor feasible to(More)
These studies evaluated the ability of common household food and drink products to mask the bitter taste of three selected anti-terrorism drugs. Three anti-terrorism drugs (doxycycline, ciprofloxacin hydrochloride, and potassium iodide) were mixed with a variety of common household food and drinks, and healthy adult volunteers evaluated the resulting taste(More)
Development of antiviral products for certain highly pathogenic viruses with limited available treatments, such as viruses that may have biothreat potential, is critically important and challenging. The mission of the FDA is to protect the public health by assuring the safety, efficacy and quality of such products. Human clinical trials are critically(More)
We reviewed information about the safety and plasma pharmacokinetic data for amoxicillin, specifically related to its potential use for postexposure inhalational anthrax. Amoxicillin (45 mg/kg/d) given orally in 3 divided doses to pediatric patients <40 kg should yield an adequate time above the MIC for susceptible Bacillus anthracis (< or =0.5 microg/mL)(More)