title: Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective.
abstract: For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.
authors.affiliation: Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Building 51, Room 4166, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, USA. david.hussong@fda.hhs.gov
authors.forename: David
authors.initials: D
authors.lastname: Hussong
mesh_terms: D017277:Drug Approval; D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination / Q000331:legislation & jurisprudence* / Q000517:prevention & control*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005544:Forecasting; D033161:Government Regulation; D013242:Sterilization / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration