Navigating Regulatory Challenges: A Collaborative Journey to FDA Approval

Puzzle pieces uncovering a seal of FDA approval

Case Study Zachary Swan, PhD (Director, Regulatory Affairs) Background and Challenge Allucent was approached by a commercial-stage biopharmaceutical company focused on infectious diseases to provide writing and strategy support for their unique and complex New Drug Application (NDA) with multiple indications. The company faced a significant challenge when the FDA’s assessment deemed their initial studies in […]

Pre-IND Meeting Guide: Benefits & How to Prepare

Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic products. This meeting, known as a pre-IND meeting, is intended to address specific questions related to the initial US clinical study (also known as a first-in-human […]

Roadmap To Marketing Authorisation in Europe: Taking All the Right Turns

Approval of your Marketing Authorisation Application (MAA) is the final hurdle to pharmaceutical product launch in Europe. Adequate and timely navigation of this roadmap is essential to achieve a successful review by the EMA. Navigation of the drug development pathways towards MAA approval starts much earlier than you may know till date and is essential […]

FDA Orphan Drug Designation for Rare Diseases

An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been historically low compared to conditions with a higher prevalence. This is mostly due to the financial risks of recouping the costs of drug development. In […]

CAR T-Cell Therapy Challenges to Development & Approval

Chimeric antigen receptor T-cell (CAR T) therapy is a revolutionary immunotherapy that uses cells from the patient’s immune system to fight certain kinds of cancer. The first two FDA approved CAR T therapies, Yescarta™ and Kymriah™, were both approved in 2017. Former FDA Commissioner, Scott Gottlieb, noted the significance of these approvals in his October […]

What is a 505(b)(2)?

The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for which the applicant has not obtained right of reference. In other words, the 505(b)(2) pathway enables investigators and/or manufacturers to apply for approval without having […]

Strategizing for Your Submission: Planning Ahead for Your NDA or BLA

Pharmaceutical marketing applications, whether a new drug application (NDA) or biologic licensing application (BLA), are massive undertakings. They can contain tens to hundreds of thousands of pages of documents. Therefore it behooves a sponsor to plan such an application well in advance. Often planning for the application is postponed until the pivotal Phase 3 clinical […]

What are the Regulatory Differences Between an NDA and BLA?

To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs. While they share the same goal […]

When to Use 505(b)(1) & 505(b)(2) Pathways for New Drugs and Common Misconceptions

A fundamental question for any drug development program is which regulatory pathway to pursue. The answer is important to determine early on, because it dictates the scope of clinical and nonclinical studies that need to be conducted and how the marketing application will be presented to regulators. It also heavily influences a host of other […]

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 […]