How to File Post-Approval Changes to an NDA or ANDA
On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress. Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act...
Quality & Compliance
United in Diversity: Six Tips for European Batch Release
Europe consists of 44 countries, and 21 supranational organizations and within the EU alone there are 24 official languages. So, how do you navigate the differences across Europe in the EU? And more...
Meet the Expert: Anchal Choudhuri
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
Best Practices to Reduce Impurities in Generics
Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After...
How to Prepare for the Three Type B Meetings with the FDA
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...
Regulatory Sciences
How to Understand and Avoid Common Phase 3 Failure Points
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
Regulatory Sciences
Meet the Expert: Carrie Rabe
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
The Anniversary We Didn’t Want: One Year of COVID-19 Milestones
On March 11, 2020, after months of researching, strategizing, and meeting with various leaders and medical experts globally, the World Health Organization (WHO) declared COVID-19 to be a global...
Understanding FDA Pre-ANDA Meetings
Brought into being by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), the FDA’s pre-ANDA program is designed to accelerate access to generic versions of complex products. The...
Regulatory Sciences
The Unique Challenges of Gaining Approval for Drug-Device Combos
A combination product is composed of any combination of a drug and a device; a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. Consider...
Regulatory Sciences
How to Manage the Risk of Elemental Impurities with ICH Q3D
How to Manage the Risk of Elemental Impurities with ICH Q3D: The mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to ensure...
What It Takes to Be Successful with GDUFA in 2021
GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022. The continuing goal of the amendment is to facilitate timely access to high-quality,...
Regulatory Sciences
Brexit: New Regulatory Opportunities in the United Kingdom
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...
Overcoming High-Risk Situations and Tight Deadlines: How to Successfully Complete Due Diligence
Much like buying a home as an individual, a company contemplating the acquisition of a new product or business requires a lot of research and fact checking. In both situations, it is critical for the...
Regulatory Sciences
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
Top 9 Failure Points During Nonclinical Development
The process of drug development involves clinical and nonclinical studies. Nonclinical studies are considered crucial for understanding the safety of new drugs. Before testing a drug in people,...