March 2016

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Pulmonary Studies

 

Industry News

New FDA Draft Guidance for Biologics

The Food and Drug Administration (FDA) has released a new draft guidance for biologics titled Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009. The draft guidance focuses on four major topics: (1) what will happen to approved applications for transitional products on March 23, 2020; (2) what will happen to pending applications; (3) how sponsors with pending applications should prepare; and (4) how exclusivity will be affected.

 
See the Draft Guidance

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Do you have a question about your drug development program or a clinical trial? Get access to some of the industry's leading experts here.

Mira Francis, B.Pharm., PhD, MBA, Director, Medical Science Liason in Phase I/II

Renal Impairment

Dr. Mira Francis, B.Pharm., PhD, MBA, Director, Medical Science Liason in Phase I/II recently presented at the Outsourcing in Clinical Trials Canada conference on renal Impairment. Click below to view the slides from her presentation "Impaired Renal Function Clinical Trials: How to Minimize Risks and Accelerate Timelines."

Jim Carlson, President and CEO of Algorithme Pharma USA

Bioequivalence

Dr. Jim Carlson, PharmD, and his team at our Fargo, ND facility have conducted more than 20,000 clinical pharmacology studies in a variety of therapeutic areas such as asthma, allergies, dermatology and diabetes. Dr. Carlson is a renowned pioneer and leader in the bioequivalence sector with more than 30 years of industry experience.

More info
More info

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Award Winners

Altasciences is proud to announce that Algorithme Pharma and Vince & Associates have both been awarded a collective twelve CRO Leadership Awards in all categories: Capabilities, Compatibility, Experitise, Quality and Reliability.

Our New Publication

Members of our bioanalysis team are proud to have co-authored: 9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

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