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Latest News | 12 April 2012

As Final Guidance is Released, Deadline for PET Drug Compliance Draws Near

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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 [Read More...]

Tags: Aseptic drug FDA GMP Oncology PET Pharmaceutical Sterile
Latest News | 10 April 2012

FDA Publishes New Guidance on PET Drug GMPs

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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 [Read More...]

Tags: Aseptic drug FDA GMP Oncology PET Pharmaceutical Sterile
Regulatory Update | 5 April 2012

Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers

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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 [Read More...]

Tags: Alzheimers Alzheimer's Biomarkers Disease EMA Europe Guidance PET
Latest News | 27 February 2012

FDA Releases New Draft Guidance on PET Drug Products

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The US Food and Drug Administration (FDA) released new draft guidance 27 February on Positron Emission Tomography (PET) drug products.FDA notes that Guidance: FDA Oversight of PET Drug Products [Read More...]

Tags: Answers Draft Guidance drug FDA Guidance PET Pharmaceuticals Positron Emission Tomography Q&A Questions
Latest News | 6 February 2012

FDA Releases New Draft Guidance on Positron Emission Tomography Products

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The US Food and Drug Administration (FDA) released new draft guidance for industry on 3 February that covers the regulation of positron emission tomography (PET) drugs.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 [Read More...]

Tags: ANDA Draft Guidance FDA NDA PET Positron Emission Tomography Q&A Questions and Answers