Key IND-Enabling Studies
An Investigational New Drug (IND) application is required by the U.S. Food and Drug Administration (FDA) before any clinical studies in humans may be conducted. For new drugs and even for most follow-on products (besides generics), the results of certain nonclinical studies, known as IND-enabling studies, must be submitted with the IND application to support […]
5 Common FDA Applications for Drugs & Biologics
There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA): The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category. Over-the-Counter (OTC) drugs […]
9 Tips for Preparing a Successful New Drug Application (NDA)
1. It’s never too early to start planning for your NDA From the time you begin preparing for your Pre-IND meeting and IND submission, and well before you’ve dosed a single patient, you should start thinking about your eventual NDA. For example: All these questions (and many more) should be front and center in your […]
Getting your ducks in a row: Successful Management of Large eCTD Submissions
Original Air Date: Wednesday, November 6, 2019 Time: 10 am (EST) | 7 am (PST) | 3 pm (CET) Once gap-analysis of your marketing or investigational new drug application has been completed, Cato Research recommends that planning for the submission of the eCTD application begin. While many companies treat the actual compilation and submission of […]
What is IVIVC?
An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage form and a relevant in vivo response. When performing IVIVC for formulation development, the in vitro property is primarily dissolution or drug release and the in vivo response is primarily a drug’s plasma concentration or the amount/rate of drug absorbed.1. In […]
Surrogate Endpoints – Neither the End nor the Point
In an article published in June 2018 in JAMA Oncology, the FDA reviewed their accelerated approvals for malignant hematology and oncology drugs over the previous 25 years. In an earlier post, we reviewed the accelerated approval pathway. This expedited option is for drugs that provide a meaningful advantage over available therapies for serious conditions. The approval decision via […]
What to Expect following Your Marketing Application Submission
Submitting a marketing application to the FDA is only the first in a cascade of events that lead to products being approved. However, this flurry of activity is not solely on the side of the regulators – there are also Sponsor-side responsibilities to be considered. Failing any one of these could unnecessarily jeopardize or delay […]
The Path to IND Part 2: Supporting Clinical Study Design and Dosing
Introduction In part one of this blog series, “The Path to IND Part I: Milestones and Common Roadblocks,” we introduced the FDA’s Investigational New Drug (IND) application and highlighted some of the most common mistakes drug developers make and how to avoid them. Among our keys to IND success in Part 1 were: In part […]
The Path to IND Part 1: Milestones & Common Roadblocks
The Investigational New Drug (IND) application is the primary pathway through which new drugs and biologics are approved to be tested in humans. But, what exactly is an IND and does your program really need one? What are the requirements for a successful IND and what paths can you take to get there? In this […]
What is the Difference Between ANDAs & 505(b)(2) NDAs?
An Abbreviated New Drug Application (ANDA) contains data which is submitted to the FDA for the review and potential approval of a generic drug product whereas a New Drug Application (NDA) is the application through which sponsors formally propose the approval of a new pharmaceutical drug. Media attention in drug development tends to focus more on novel therapies than […]