What’s It All About?—KASA

What’s it all about, KASA?By Mary Waters There’s been some buzzing about the FDA instituting a new review system called Knowledge-aided Assessment and Structured Application (KASA). In September 2018, the FDA met with the Pharmaceutical Science and...

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HW was at FDA for the Part 15 public hearing

By Nitisha Pyndiah, PhDHW reportsHW was at FDA for the Part 15 public hearing on facilitating competition and innovation in the biological products marketplace On September 4, 2018, FDA held a public hearing to hear comments from different stakeholders on FDA’s...

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Hyperlinks

By Mary Waters, Senior Consultant, eCTD Publish Services Noun; a link from a hypertext file or document to another location or file, typically activated by clicking on a highlighted word (typically blue colored text) or an image on the screen. There is a method to the...

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It’s NOT a Snowman, it’s SNOMED!

By Mary WatersThe FDA updated their Form FDA 1571 and Form FDA 356h in May 2018 to include a few new fields; 6B, 7B, and 15B. This change on the Form FDA 1571 now includes the SNOMED CT Indication Disease Term. SNOMED CT is the acronym for Systematized Nomenclature of...

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BsUFA II fees—are you aware of the major changes?

By Nitisha Pyndiah, PhD The FDA guidance document Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 explains the changes, but let’s review the most important items. Quick introduction The Biosimilar User Fee Act of 2012 (BsUFA I) added sections to...

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FDA Public Docket for Technical Specifications

By Mary Waters Here’s Your Opportunity to be Heard The Food and Drug Administration (FDA) has established a public docket so that anyone can share information, comments, and ideas on any matters related to the use of their technical specifications or technical...

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Update to the eCTD “Mandate”

By Mary WatersThe FDA had a mandate for submitting in eCTD format Drug Master Files (DMFs) (other than Type III – packaging material). Luckily for some, there was a reprieve as the FDA extended that date another year until 05 May 2019. That said, there are still other...

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What Do You Need to Know About Immunogenicity?

By Nitisha Pyndiah, PhD One of the most challenging parts of your drug development is making sure that your drug does not elicit a detrimental immune response in the patient also known as immunogenicity. This immunogenic response can impact the efficacy and safety of...

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