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  • Regulatory NewsRegulatory News

    FDA Warns Massachusetts PET Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Woburn, Massachusetts-based PETNET Solutions Inc. after an inspection last spring uncovered unclean conditions and failures in environmental monitoring for the positron emission tomography (PET) drug manufacturing site’s aseptic operations. The letter notes that the FDA inspector “observed a state of disrepair and lack of cleanliness” at the site, while “sporeforming fungi were repeat...
  • Regulatory NewsRegulatory News

    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
  • FDA Releases Long-Awaited Guidance on PET Drugs

    The US Food and Drug Administration (FDA) has released the final version of a long-awaited guidance on positron emission tomography (PET) drugs, nearly 10 months after first releasing the draft version for public consideration. PET drugs are diagnostic radiopharmaceuticals used in conjunction with a PET device, and are commonly used in oncology and neurology screenings. "The dual photons that emerge from the positron annihilation are detected by PET scanning devices to...
  • FDA Clears Mayo Clinic to Manufacture PET Drug

    Regulators with the US Food and Drug Administration (FDA) have approved the manufacture of an existing positron emission tomography (PET) drug for use at a new facility, the agency has announced. The drug, Choline C 11 Injection, is used to help detect the presence of recurrent prostate cancer. The drug is administered to patients intravenously, and is specifically indicated for patients whose blood prostate specific antigen (PSA) levels have risen despite earlier trea...
  • As Final Guidance is Released, Deadline for PET Drug Compliance Draws Near

    Manufacturers of positron emission tomography (PET) drugs have until 12 June 2012 to comply with new regulations posted by the US Food and Drug Administration (FDA) on 10 April, reports In-Pharma Technologist . As Regulatory Focus previously reported, FDA has released draft guidance for FDA Oversight of PET Drug Products- Questions and Answers on 27 February, and released final guidance under the same name on 10 April. While the comment period for that final gu...
  • FDA Publishes New Guidance on PET Drug GMPs

    The US Food and Drug Administration (FDA) is releasing a final guidance on positron emission tomography (PET) products to help manufacturers of the drugs meet the agency's requirements for good manufacturing practices. FDA's guidance, Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs , deals with sterile manufacturing practices for PET products. "Most PET drugs are designed for parenteral administration and are produc...
  • Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers

    Under a voluntary new scientific pathway, the European Medicines Agency (EMA) adopted two innovative biomarkers for use in the development of new medications for Alzheimers submitted by Bristol-Myers Squibb: PET amyloid imaging (positive/ negative) as a biomarker for enrichment for use in predementia AD clinical trials , and use of CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative) . The new process can lead to either a Committee for Medicinal Produ...
  • FDA Releases New Draft Guidance on PET Drug Products

    The US Food and Drug Administration (FDA) released new draft guidance 27 February on Positron Emission Tomography (PET) drug products. FDA notes that Guidance: FDA Oversight of PET Drug Products Questions and Answers "provides [98] questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user f...
  • FDA Releases New Draft Guidance on Positron Emission Tomography Products

    The US Food and Drug Administration (FDA) released new draft guidance for industry on 3 February that covers the regulation of positron emission tomography (PET) drugs. The guidance is intended to address numerous aspects of the drug regulatory process, including the submission and review of an application, regulatory compliance, inspections, registration and listing and associated user fees. Guidance: FDA Regulation of PET Drug Products - Questions and Answers shoul...