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