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  • Regulatory NewsRegulatory News

    FDA Looks to Modernize Sterile Injectable Inspections

    With an eye toward averting drug shortages and sterility question marks, the US Food and Drug Administration (FDA) is modernizing its inspections program with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs. The New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a more structured manner for more consistent facility oversight and faster and more ...
  • Regulatory NewsRegulatory News

    FDA Warns of Dosing Errors With Compounded Injectables

    The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors.   "Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently," FDA writes.   For small volume parenteral drugs a...
  • Regulatory NewsRegulatory News

    FDA Bans Imports From Teva’s Hungary Plant Except Two Drugs in Shortage

    The US Food and Drug Administration (FDA) late last week announced an import alert prohibiting drugs made at the  Gödöllő, Hungary-based manufacturing site from entering the US. However, Teva spokeswoman Denise Bradley told Focus that the ban does not include two drugs that are medically necessary and currently in short supply in the US. Those two drugs are the infection treatment Amikacin and the chemotherapy Bleomycin. “The import alert was issued on May 27 and w...
  • Regulatory NewsRegulatory News

    WHO Offers New Plan to Limit Drug Shortages

    The World Health Organization (WHO) released a new report this week on ways to address global drug shortages, which are increasing in frequency, particularly for old, off-patent or difficult to formulate treatments. Difficulties in acquiring raw materials, manufacturing problems, barriers to competition, business decisions, the impact of new technologies, expensive medicines and fragmented markets were all listed as reasons for new drug shortages based on studies in seve...
  • Regulatory NewsRegulatory News

    FDA Releases Draft Guidance on Injectable Drug Dose Labeling

    Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses. The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products. Single-Patient-Use The introduction of this new term, "single-patien...
  • Regulatory NewsRegulatory News

    Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors

    The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices. In a 25 February 2015 safety announcement, FDA said the new warnings are meant to "reduce the serious risk of infection" when users share insulin pens and other injectable diabetes medications, "even [when] the needle is changed." "Sharing pens can result in the sp...
  • Citing Safety Concerns, FDA Guidance Takes Aim at Practice of Overfilling Injectable Vials

    The US Food and Drug Administration (FDA) today issued a new draft guidance document clarifying its standards for filling injectable drugs and biological products. Background Liquid products must often be administered through an intermediary, such as a syringe. Unlike a solid pharmaceutical tablet, which contains the full dose in solid form, a vial of liquid product usually contains more than the recommended dose since it may be difficult or impossible to remove 100% ...
  • China Sets Deadlines for Drug GMP Implementation

    China's State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December 2012, a joint notice to the provinces and municipalities setting forth deadlines for implementation of the revised good manufacturing practices (GMPs) by the pharmaceutical industry.  Injectable drug manufacturers must implement the revised GMPs by 1 January 2014, a...
  • Spotlight on Counterfeiting After Fake Avastin Found in US

    Counterfeit copies of Avastin-an oncology drug with numerous indications-is casting a harsh spotlight on the safety of the pharmaceutical supply chain and causing experts to ask how it can be strengthened. Perhaps the most prominent idea put forth by experts is a so-called 'track and trace' system for verifying pharmaceutical integrity. The US Food and Drug Administration (FDA) is expected to release a proposal for such a system within the coming year, notes the Associ...