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 […]
Improving Informed Consent in Clinical Trials
Does more information mean better knowledge? Recruitment and retainment of patients for clinical trials can be a major challenge, especially for complex areas such as oncology since the accumulating knowledge in these areas leads to a major increase in the types of therapies under development. The field is expanding, both in the approaches used, from […]
The Value of Orphan Drug Designation in your Drug Development Program
Original Air Date: Tuesday, July 28, 2020 Time: 11:00 AM EST/4:00 PM London As a drug developer you may wonder if you have a portfolio product or development candidate that qualifies as an orphan drug and thus provides options unique to orphan drug development. There are approximately 7000 known rare diseases and more expected to be […]
What’s New Health Canada?
What’s New in: Updates from Health Canada New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device 09 April 2020 Type of Update and Link Date Posted Guidance Document – Preparation of […]
Consideration for Ongoing Clinical Trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic
1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications may be required and protocol deviations may […]
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 […]
Three Blockbuster Approved Cancer Drug Launches Expected in 2020
2019 has been an outstanding year for biotechnology companies developing anti-cancer drugs, as seen from the large number of approvals given by the Food and Drug Administration (FDA) (approximately 25% of all drug approvals for 2019 were for oncology drugs). These rapid approvals are paving the road for new anti-cancer drug launches, with a total of 27 drugs […]
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 […]