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A follow-up study performed by HHS' Office of Inspector General (OIG) confirmed that some pharmaceutical firms in 2002 overcharged public-health facilities participating in a federal drug-discount program by tens of millions of dollars.
To ensure the quality and consistency of human gene therapies, sponsors of investigational new drug applications (INDs) should conduct ongoing studies to evaluate the identity, quality, purity and strength of the products throughout the manufacturing process, according to a draft guidance released by the FDA.
The FDA will commission the Institute of Medicine (IOM) to evaluate the U.S. drug safety system and assess the FDA's role in delivering safe and effective drugs to the public, the agency announced yesterday.
The FDA has issued a draft guidance for designing and conducting pharmacokinetic (PK) studies in pregnant women that aims to stimulate R&D of appropriate treatments for such patients.
The time it takes for a dietary supplement manufacturer to assemble the scientific information needed to support a labeling claim will depend on the product and the claimed benefits -- a process that can be as short as one hour, according to the FDA.
Replacing the traditional egg-based flu vaccine with a cell-based version could help the U.S. prevent future vaccine shortages, according to the director of the National Institute of Allergy and Infectious Diseases.
Abbott Laboratories has been cited by the FDA for a pair of direct-to-consumer promotional pieces that exaggerate the benefits of its HIV drug, Kaletra, while omitting significant risk information.
The FDA has issued a question-and-answer draft guidance that clarifies changes made by the Medicare Modernization Act (MMA) in relation to the generic drug approval process.
In an ironic move, a major brand drugmaker has encouraged its workers to opt for generic pharmaceuticals and OTC medications, as well as purchase their medicines through the mail to help the company lower its healthcare costs.
The Division of Bioequivalence (DBE) in the FDA’s Office of Generic Drugs hopes the addition of more reviewers will help reduce the long wait for generic drug application approvals, according to the division’s chief.