The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    EMA Adds New Excipients to Labeling Requirements

    The European Medicines Agency (EMA) on Monday updated its annex to the European Commission's guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others. Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are thought to be inactive, though some can cause reactions in certain circumstances. For instance, lactose is commonly used as a filler in drug tablets, ...
  • Regulatory NewsRegulatory News

    European Commission Recommends Changes to SmPC, Package Leaflets

    The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs. In its report, the Commission says that the European Medicines Agency (EMA) should update its guidelines to improve the comprehension and readability of package leaflets (PL) and summary of product characteristics (SmPC) to safe use of drugs in the EU. The report itself takes into account the resul...
  • Regulatory NewsRegulatory News

    FDA's Electronic Drug Labeling Proposal Comes Under Fire

    The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk. Background In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Prod...
  • Study Calls for Additional Regulation of Package Labeling

    To hear Laura Bix's analysis, it's a wonder more people aren't hurt each year by the medications they take. In a study published in the online medical journal The Public Library of Science: One , Bix, an associate professor at Michigan State University, and colleagues looked at how consumers analyze information presented on drug labels in the form of additional prescription drug warning labels (PWLs)-the small stickers on drug packaging imploring you to take heed of imp...
  • FDA Releases Adverse Event Guidance for Small Businesses

    The US Food and Drug Administration (FDA) wants to help small businesses comply with regulations pertaining to adverse event reporting. In 2008, the agency released a new regulation directing all companies to include a hotline number for FDA's adverse event reporting service, which collects information about safety issues. The number must coincide with an explanation of what the number is, and that it is not intended for dispensing medical advice. In its 14 June guidanc...
  • MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

    Some medicines approved to treat attention deficit hyperactivity disorder (ADHD) in the UK will soon include information in the patient information leaflet specifically targeted towards those under the age of 18 thanks to a partnership between regulators, academia and industry. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday, 7 June it is moving to implement the new information layout-reportedly the first time it has been done in th...
  • Sandoz Issues Recall After Packaging Errors Found

    Novartis AG subsidiary Sandoz announced on Wednesday, 6 June the initiation of a recall for ten lots of its oral contraceptive Intravole (levonorgestrel) after consumers notified the company of a packaging mix-up. Sandoz said the packaging error resulted in pills containing placebos being placed incorrectly within the blister packs, opening the possibility of consumers taking the oral contraceptives at the incorrect time. The blister packs ordinarily contain the placebo ...