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...

read more

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...

read more

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...

read more

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...

read more