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  • Regulatory NewsRegulatory News

    EMA Highlights Central Nervous System Drug Development Challenges

    The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia. "Research into medicines for CNS is complex, with a higher rate of failure during the clinical development of these products compared to other fields of medicine," EMA says. To conduct its analysis, EMA says its staff members reviewed a total of 103 a...
  • Regulatory NewsRegulatory News

    Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster

    A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...
  • FDA Calls for Evaluation of Suicidal Ideas and Behavior in all CNS Drug Trials

    A new draft guidance released by the US Food and Drug Administration (FDA) addresses suicidal thoughts and behavior occurring in clinical trials and how to proactively assess the risks during drug development stages. FDA's 14 August 2012 draft guidance, Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials , focuses on pharmaceutical and biological products, and in particular on psychiatric and nonpsychiatric drugs. FDA explains t...
  • Advisory Committee Lends Limited Support to Pfizer's Tafamadis

    The US Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on 24 May to partially support Pfizer's drug, tafamadis, which is looking for FDA approval to treat a rare neurodegenerative disease. The panel voted 13 to 4 against the drug in an initial vote, saying study data did not show the drug to be effective in directly slowing the progression of familial amyloid polyneuropathy (FAP). The committee later voted again, ...
  • Report: FDA Taking Longer to Approve Drugs With 'Unmet Medical Needs'

    A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve pharmaceutical products for some areas of unmet medical need as the result of unclear regulatory standards. The report, " Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation ," is a follow-up to one co-authored by CHI and BCG in 2011. The 2011 report notes FDA...
  • Brazil: Advisory Council Discusses New ANVISA

    ANVISA's Advisory Council -a group including representatives of the National Confederations of Industry (CNI), Commerce (CNC) and Health (CNS) and councils that represent the health secretaries of Brazilian states and municipalities-came together to discuss the new structure of the Brazilian regulatory agency at its 38 th meeting on 18 April 2012. The restructuring also resulted in the development of a Strategic Plan for the agency for the coming years, which the Counc...
  • FDA Releases Exceptions to Labeling Requirements for Strategic National Stockpile

    The US Food and Drug Administration (FDA) released a new final rule on 6 February 2012 that allows FDA center directors leeway in the labeling requirements for products held at the Strategic National Stockpile (SNS). SNS is a stockpile of drug products to be used in the case of a national emergency, such as an outbreak of disease. Products at the stockpile are frequently overseen by FDA due to the need for continued stability testing and labeling updates. Instead of repl...