• Regulatory NewsRegulatory News

    EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines

    The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age.  The public element of the meeting means EU citizens will be invited to share their experiences with these medicines, which are approved nationally in the EU to ...
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    New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women

    The U.S. Food and Drug Administration (FDA) on Wednesday warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect the development of children’s brains. The warning comes as FDA says recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikel...
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    FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard

    The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today. Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce labeling uniformity were first passed. Those measures were substantially updated in 2006 under FDA's ...
  • Ireland: HIQA Releases Economic Evaluation of Repeat Universal Antenatal Screening for HIV in the Third Trimester of Pregnancy

    A report issued by Ireland's Health Information and Quality Authority (HIQA) contains advice on whether a change in the existing Irish guidelines for the management of human immunodeficiency virus-1 (HIV-1) in pregnancy is warranted. The conclusion is that the cost of introducing repeat universal antenatal HIV screening in the third trimester is high compared to the expected benefits. In the context of a finite healthcare budget, consideration must be given to the e...
  • EMA Releases Concept Paper on Excipient Labeling

    The European Medicines Agency (EMA) released a concept paper on 8 March about the need to revise current labeling guidelines for medicines containing excipients . Current guidelines contain warnings about the presence of certain excipients, particularly those pursuant to 2001/83/EC Article 54(d) which states that all excipients must be declared if a product is an injectable product or eye preparation. Further, all excipients know to have an action or effect on the body ...