Category Archives: Industry News

New FDA Guidances for February 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  … Continue reading

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New FDA Guidances for March 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in March, are posted.  In addition, upcoming Advisory committee meetings, other public meetings hosted by FDA, as well … Continue reading

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New FDA Guidances for February 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February, are posted.  In addition, the upcoming Advisory committee meetings and other public meetings hosted by FDA are … Continue reading

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FDA’s Comprehensive Status Report on Personalized Medicine

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA published a report, prepared by the Office of the Commissioner in the Office of Medical Products and Tobacco, in October 2013 entitled “Paving the Way for Personalized Medicine: … Continue reading

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New FDA Guidances for December 2013

Special Interest Guidances/Information Date Posted Guideline for Industry and Food and Drug Administration Staff – Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate 30 Dec 2013 Naming of Drug Products Containing Salt Drug Substances (PDF – 161KB) 24 Dec … Continue reading

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