Premier Research Announces Milestone Investigational New Drug Application
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Premier Research Group Limited has announced that it has submitted an Investigational New Drug Application which represents the 50th IND under management.
The milestone IND was submitted to the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), and is intended to support the clinical development of a novel formulation of a non-steroidal anti-inflammatory drug for the treatment of pain.
“This submission to DAARP expands our considerable experience in CDER Divisions and supports a development program for a new drug as a 505(b)(2) NDA, a strategy used by many small to mid-sized biopharmaceutical companies”, noted James Ottinger, Vice President, Global Consulting and Compliance.
Premier Research acquired its U.S. regulatory affairs capabilities in 2006 in order to provide regulatory consulting to its U.S. and Internationally-based clients.
The milestone IND was submitted to the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), and is intended to support the clinical development of a novel formulation of a non-steroidal anti-inflammatory drug for the treatment of pain.
“This submission to DAARP expands our considerable experience in CDER Divisions and supports a development program for a new drug as a 505(b)(2) NDA, a strategy used by many small to mid-sized biopharmaceutical companies”, noted James Ottinger, Vice President, Global Consulting and Compliance.
Premier Research acquired its U.S. regulatory affairs capabilities in 2006 in order to provide regulatory consulting to its U.S. and Internationally-based clients.
