• Regulatory NewsRegulatory News

    Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

    A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint, and not a compendial approach as espoused in the US Pharmacopoeia’s (USP) Chapter 790 method.   Stephen Langille, senior microbiology consultant with ValSource, Inc, and a former microbiologist with the ag...
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    USP seeks input on mRNA analytical testing guide

    The United States Pharmacopoeia (USP) has released a new draft chapter proposing a set of analytical procedures and best practices to accelerate product development and support quality assessments for mRNA-based vaccines and other therapies, such as treatments for cystic fibrosis and certain cancers.   USP and global stakeholders have “identified a need for analytical procedures and best practices to support the assessment of common quality attributes of mRNA vaccine...
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    FDA addresses establishment of inspection programs for injectables

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.   The 18-page draft guidance "addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inpsection techniques, particulate identification, inves...
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    Pharmaceutical officials propose new USP harmonized chapter on visual inspections

    Pharmaceutical industry officials have proposed the United States Pharmacopeia (USP) develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps. This chapter would be developed with input from the European Pharmacopeia and the Japanese Pharmacopeia. Such a chapter would allow for more robust detection of visible particles in these drugs, which is a common reason for reason for recalls and warning letters in the US,...
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    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.   Background   New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the US...
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    Groups Protest Senate Bill’s Provision to Exempt Biologics From USP Standards

    Ten groups, including the US Pharmacopeial Convention (USP) and Biosimilars Council, are taking major issue with a provision in a seemingly innocuous bill to boost the workforces of the US Food and Drug Administration (FDA) and National Institutes of Health (NIH). In a letter sent on Monday to Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), the American Pharmacists Association, ASHP, Academy of Managed Care Pharmacy, National Community Pharmacists Association and o...
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    USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards

    USP CSO Jaap Venema (right) signs agreement with Russian FDA Roszdravnadzor. The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things. The agreement, which is an extension of an existing MOU instituted in 2009, means USP and the Federal...
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    FDA Finalizes New Approach on Naming Drugs Containing Salt Drug Substances

    The US Food and Drug Administration (FDA) has finalized a new policy detailing how manufacturers of drug products containing salts should name their products. Background The guidance document, Naming of Drug Products Containing Salt Drug Substances , was first released in draft form in December 2013 following the May 2013 implementation of the US Pharmacopoeia's (USP) monograph on naming new drug products, Monograph Naming Policy for Salt Drug Substances in Drug P...
  • 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% ...
  • USP Sets Date for Overhaul of Monograph Naming Policy

    • 20 November 2012
    The US Pharmacopeia (USP) has released a new policy it says will bring both clarity and consistency to the naming of new drug products based on their clinically active components. In a 19 November 2012 press release, USP said the new naming policy will come into effect on 1 May 2013, and will apply prospectively-not retroactively-to all drug product and compounded preparation monographs appearing in its compendia. The new policy, Monograph Naming Policy for Salt Dru...
  • USP Standard Aims to Reduce Medication Errors through Standardized Labeling

    The US Pharmacopoeia (USP) has announced a new "universal" standard for the content and appearance of prescription container labels, a response to what it says is a surge of medicate misuse resulting in part from non-standard and confusing labeling formats. "Wide variability in prescription container labels exists today across individual prescriptions, pharmacies, retail chains and states," USP explained. The new standard, it said, will provide guidance based on resear...
  • FDA, USP Devices to Fight Counterfeit Medicines

    The US Food and Drug Administration (FDA) has developed a new tool it contends will assist the agency in its fight against counterfeit drug products, reports Med Page Today . The device, known as the Counterfeit Detection Device Number 3, or CD3, emits 10 wavelengths of light over products, including the packages and certifying documents they come with. The wavelengths, comprised of both visible and invisible spectrums, alert inspectors to potential issues and likely fo...