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 Waters, Senior Consultant, eCTD Publish Services The 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...

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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 Waters The 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...

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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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FDA Interchangeability Guidance Part 2

  By Nitisha Pyndiah, PhD To follow up our previous part 1 about the analytical data required to demonstrate interchangeability, let’s look into the clinical studies required. What clinical studies are required to demonstrate interchangeability? To demonstrate...

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May 5th Marks the Deadline for INDs and DMFs

By Mary Waters Cinco de Mayo is widely interpreted as a celebration of Mexican culture and heritage. Today, celebrators mark the occasion with parades, parties, mariachi music, Mexican folk dancing and traditional foods such as tacos and mole poblano and consuming...

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HW reports advice from FDA, CDER reviewers

What are the benefit-risk considerations during the development of your drug and how to avoid clinical hold? On September 27-28, the FDA SBIA REdI Fall Conference took place in Rockville, MD. HW was there and reports highlights of the drug track of the meeting. FDA...

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