Author: Anne B. Claiborne

The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA’s science base must be strong enough to make certain that regulatory decisions are based …

The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA’s science base must be strong enough to make certain that regulatory decisions are based …

Whether or not the United States has safe and effective medical countermeasures–such as vaccines, drugs, and diagnostic tools–available for use during a disaster can mean the difference between …

Whether or not the United States has safe and effective medical countermeasures–such as vaccines, drugs, and diagnostic tools–available for use during a disaster can mean the difference between …

Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether …

Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether …

An estimated 8.8 million people fell ill with tuberculosis (TB) in 2010 and 1.4 million died from the disease. Although antibiotics to treat TB were developed in the 1950s and are effective against a …

An estimated 8.8 million people fell ill with tuberculosis (TB) in 2010 and 1.4 million died from the disease. Although antibiotics to treat TB were developed in the 1950s and are effective against a …

The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and …

The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and …

There is growing recognition that the United States’ clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired – where medical care is provided solely based on …

There is growing recognition that the United States’ clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired – where medical care is provided solely based on …

Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite …

Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite …

To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of …

To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of …

Multidrug-resistant tuberculosis (TB) is caused by bacteria resistant to isoniazid and rifampicin, the two most effective first-line anti-TB drugs, originally developed and introduced in the 1950 and …

Multidrug-resistant tuberculosis (TB) is caused by bacteria resistant to isoniazid and rifampicin, the two most effective first-line anti-TB drugs, originally developed and introduced in the 1950 and …

Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors …

Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors …

Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond …

Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond …

The field of endeavors known as regulatory science has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other …

The field of endeavors known as regulatory science has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other …

The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the …

The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the …