title: Developing regulatory strategy for microbicides.
abstract: Ever since the discovery that a virus was responsible for AIDS, prevention of HIV infection has been a drug/vaccine development target in therapeutic research. Microbicide products are a viable, globally applicable option; however, to date, no product has been approved anywhere in the world. Development of such a product will need to account for the changing disease landscape and will need to leverage available regulatory pathways to gain approvals in the developed world and emerging markets. In countries where the regulatory pathway is not clear which is the case in several emerging markets, sponsors will need to employ a flexible approach to gather and meet local regulatory requirements and ultimately gain product approvals.
authors.affiliation: International Partnership for Microbicides, 8401 Colesville Road, Suite 200, Silver Spring, MD, 20910, USA, rnardi@ipmglobal.org.
authors.forename: Ronald
authors.initials: R
authors.lastname: Nardi
authors.forename: Linda
authors.initials: L
authors.lastname: Arterburn
authors.forename: Lisa
authors.initials: L
authors.lastname: Carlton
mesh_terms: D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D017277:Drug Approval; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000502:physiology; D006801:Humans
chemical_list: D019380:Anti-HIV Agents