Regulatory Update

Features
On 5 June 2018, a plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia. More than 160 professionals from worldwide innovator and generic pharmaceutical companies, academia, and regulatory agencies attended....
InTouch
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
InTouch
In March 2017, ISPE submitted an extensive and detailed response 1 to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics Data," 2 the associated Federal Register Notice, 3 and webinar. 4 These comments reflected ISPE's conclusion that the program, as...