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November 9, 2016
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...
April 13, 2016
FDA kicked off reauthorization negotiations for the Biosimilar User Fee Act (BsUFA) in December 2015, when the first public meeting was held on the subject. More recently, FDA met with various...
February 17, 2016
FDA will hold a public workshop in early April to discuss a proposed pilot program to enhance the safety and security of the pharmaceutical distribution supply chain. During this workshop, the Agency...
January 6, 2016
Last month, FDA published a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance was published with the intention of...
January 5, 2016
On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely,...
January 5, 2016
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...
December 8, 2015
In collaboration with the National Health Information Sharing Analysis Center (NH-ISAC) and the Department of Health and Human Services, FDA is planning to hold a public workshop entitled “Moving...
November 24, 2015
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
November 19, 2015
As we discussed in previous FDA News articles (here and here), the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s...