Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access...
Expertise: Consulting 206 results
One of the specialized capabilities in Premier Research's toolbox is coordinating the Active Substance Master File (ASMF) submission process on behalf of sponsors. The ASMF procedure (formerly known as the European Drug Master File [EDMF] procedure) has in recent years...
Preparing for regulatory submissions and interactions requires seamless communication and continuity across multiple disciplines. While many consulting companies offer regulatory project management as a capability, Premier Research Regulatory Project Managers (PMs) elevate the position by acting a single point of...
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What is 505(b)(2)?
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. A 505(b)(2) NDA contains full safety and effectiveness reports but allows at...
Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. The product...
Bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity. Discovering and developing safe and effective new medicines is a...
The three pathways to gain approval to market a drug in the United States share many common characteristics, but each is distinctly different from the others. It’s important to know in advance the strengths and weaknesses of each approach when...
On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for...
There are numerous reasons why a sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial benefits to the sponsor, providing a more convenient and/or faster-acting dosage form of a well-chosen drug...
Submission of an Investigational New Drug Application (IND) is a milestone in new drug development, marking the transition from bench research to clinical studies in human participants. Successful IND submission requires careful planning and strict compliance with regulatory requirements, which...