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  • Regulatory NewsRegulatory News

    WHO Updates Antibiotic Treatment Guidelines for Three STIs

    The World Health Organization (WHO) on Tuesday issued new treatment guidelines for three sexually transmitted infections (STIs) (chlamydia, gonorrhea and syphilis), saying the updates respond to an "urgent need" in light of increasing antimicrobial resistance. "Chlamydia, gonorrhoea and syphilis are major public health problems worldwide, affecting millions of peoples' quality of life, causing serious illness and sometimes death. The new WHO guidelines reinforce the need...
  • Regulatory NewsRegulatory News

    Updated: FDA Investigates Study Showing Yeast Infection Drug Increases Risk of Miscarriage

    The US Food and Drug Administration (FDA) said Tuesday that it’s evaluating the results of a Danish study that found a possible increased risk of miscarriage with the use of Diflucan (fluconazole), a Pfizer treatment for yeast and other fungal infections. The FDA-approved label for Diflucan says that current data do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluc...
  • Regulatory NewsRegulatory News

    Bacterial Infections Push FDA to Recall Certain Endoscope Washers

    The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection. FDA said its most recent inspection of the Custom Ultrasonics’ facility in April documented continued violations and that the company’s AERs “have been used in health care facilities that reported the transmission of serious bacterial in...
  • Regulatory NewsRegulatory News

    New FDA Guidance Clears a Path for Urinary Infection Drugs of the Future

    US healthcare product regulators have finalized a new policy set to make it easier for pharmaceutical companies to develop drugs to treat complicated urinary tract infections (cUTIs). The US Food and Drug Administration's (FDA) new guidance document, Complicated Urinary Tract Infections: Developing Drugs for Treatment , says the agency will accept either superiority or non-inferiority trials in support of a new drug application for a product intended to treat cUTIs. ...
  • New Guidance Seeks to Inform Development of Anti-HIV Product Class

    A new draft guidance published by the US Food and Drug Administration (FDA) is seeking to assist in the development of a specific class of product-vaginal microbicides-intended to prevent human immunodeficiency virus (HIV) infections. Vaginal microbicides are chemicals used to treat or prevent infections, and are most commonly physically expressed as topical gels or creams. Researchers have long hoped that vaginal microbicides could be used to prevent the spread of HIV i...
  • New FDA Guidance on Sinus Infections Focuses on Design of Clinical Trials

    A new guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors with the development of pharmaceutical products for the treatment of acute bacterial sinusitis (ABS), more commonly known as a sinus infection. The guidance is particularly focused on two aspects of development: the overall development program and the design of clinical trials used to show safety and efficacy. It does not address drugs used to prevent ABS from occurrin...
  • New Draft Guidance on Developing Drugs for UTIs

    New draft guidance from the US Food and Drug Administration (FDA) aims to assist sponsors and pharmaceutical manufacturers in the development of drugs to treat complicated urinary tract infections (cUTI). The draft,  Guidance for Industry: Complicated Urinary Tract Infections: Developing Drugs for Treatment, provides a comprehensive breakdown of both general and specific considerations necessary for developing cUTI products. These considerations include: benefit:...
  • EMA Issues Guidelines on Development of Antibacterials

    The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections . The document was approved last month at the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP) meeting, and is due to come into effect on 15 January 2012. The guideline was formulated by EMA to further clarify aspects of the antibacterial agent development process t...