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ANDAs: PRE-SUBMISSION FACILITY CORRESPONDENCE ASSOCIATED WITH PRIORITY SUBMISSIONS

As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), stakeholders agreed to pre-submission facility correspondence (PFC) to support the FDA's facility assessment, which would help to obtain a shorter GDUFA goal date for priority Abbreviated New Drug Applications (ANDAs). The recent draft guidance issued by the FDA outlines the information that should be submitted in a PFC to support this.

Altasciences has conducted thousands of bioequivalence studies, most of them being PK-endpoint studies, which were used to support ANDA submissions over the past 25 years, and has the regulatory knowledge and certifications to seamlessly guide you through the priority submission process.

 

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Ingrid Holmes, Vice President, Clinical Operations, at Altasciences Clinical Research

CANNABIS STUDIES

Over the past 10 years, we have run over 14 studies on different cannabinoids and have developed extensive experience with products delivered by inhalation. In 2017, we combined our expertise to design and conduct the world’s first safety and tolerability study on a cannabis extract smoked using a specialized delivery device that is being developed as a new chemical entity for approval by the FDA as a drug.

As Vice President, Clinical Operations, Ingrid Holmes is overseeing and ensuring the success of this recent study.

Dr. Debrah Kelsh, MD, Physician Investigator

HUMAN ABUSE LIABILITY

Debra Kelsh, MD, has acted as PI on hundreds of our clinical trials and has significant experience in the conduct of Human Abuse Liability/Abuse Potential (HAL/HAP) clinical studies.

She recently co-authored a scientific poster titled Pharmacokinetics and Abuse Potential of KP511, a Novel Prodrug of Hydromorphone, after Intranasal Administration in Recreational Drug Users where abuse potential of the drug was assessed.

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OPTIMIZING LC-MS/MS TECHNOLOGY

Altasciences' scientists describe how recent advances in LC-MS/MS technology are being leveraged in method development strategies for improved selectivity and sensitivity for the quantitation of large molecule biotherapeutics.

Opportunities in a fragmented market

In a recent interview, our CEO, Chris Perkin, discusses the fragmented state of the Early Clinical Development space and the expansion opportunities it represents for Altasciences.

EXPERTS IN EARLY CARDIAC SAFETY

With our iCardiac certified Montreal and Kansas sites and TQT expertise, we are leaders in complex cardiac safety studies. Learn more about our expertise and look out for your invitation to our upcoming Cardiac Symposium!

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