by Katrina Rogers | Jun 27, 2023 | Medical Products, Product Development
Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after one round of revision and comments on the original draft published in 2014. With this document, titled “Qualification Process for...
by Katrina Rogers | May 5, 2020 | Product Development
Part 1 – DiscoveryMay is our month to review how new medicines are developed. This will be an eight part series describing the different stages of drug development which are applicable in all regulatory jurisdictions.The aim of discovery research is to clearly...
by Katrina Rogers | Mar 17, 2020 | Medical Products
Traditionally, pharmacopoeia is a book of medicinal drugs with their effects and directions for use. Today, the pharmacopoeia are regional organizations devoted to creating and maintaining standards to ensure public health. Part of that mission includes maintaining a...
by Katrina Rogers | Jan 28, 2020 | Product Development
It appears to me that the FDA is increasing its use of medical products harmonization document as a source for regulatory guidance in recent years. For example, during the Pharmaceutical Quality Symposium in October, Tara Groen and Rapti Maudurawe of the FDA noted the...
by Katrina Rogers | Jan 23, 2020 | Product Development, Uncategorized
Similar to the MAPP discussed in a previous post, the Compliance Program Guidance Manual (CPGM) contains the instructions used by FDA personnel to perform the agency’s compliance work. Unlike the MAPP, the instructions in the CPGM are more like FDA guidance in that...
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