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The metabolism of an investigational drug should be defined early in the drug development process, and its interaction with other drugs should be explored as part of an adequate assessment of the product's safety and efficacy -- that is the recommendation from a new FDA concept paper on drug interaction studies and their implications for product labeling.
The FDA hopes a draft guidance for designing and conducting pharmacokinetic (PK) studies in pregnant women will stimulate R&D of appropriate treatments for such patients.
The FDA published a final guidance Oct. 28 addressing the use of nucleic acid tests (NATs) to screen blood donors for HIV-1 and hepatitis C virus (HCV).
The University of Arizona (UA) is in talks with the FDA and private industry to establish a nonprofit institute that would help the agency and pharmaceutical companies expedite drug development while lowering costs.
The FDA will implement an "umbrella strategy" to ensure the quality and safety of dietary supplements, the agency's acting commissioner said yesterday.
In an ironic twist, 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.
Pfizer has announced it will conduct additional long-term studies to assess the cardiovascular safety of its Cox-2 inhibitor, Bextra, as well as update the product’s labeling to include a stronger warning for serious skin rashes that have occurred in some patients taking the drug.
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 (NIAID).
The FDA has issued a final guidance document that details the vaccine labeling process, describes the agency’s review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act and discusses the type of data FDA examines when determining the adequacy of vaccine labeling.
Limiting the exposure of sterile product elements, maintaining the highest degree of environmental control, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.