Regulatory submissions and transactions with Health Canada Blog Regulatory submissions and transactions with Health Canada By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions…Rob Labriola2020 年 11 月 19 日
FDA’s New ANDA Submissions Guidance: Key Points Blog FDA’s New ANDA Submissions Guidance: Key Points The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…Rob Labriola2018 年 9 月 27 日
Achieving Compliance with the FDA’s eCTD Mandate Blog Achieving Compliance with the FDA’s eCTD Mandate The US Food and Drug Administration (FDA) has set 2018 年 5 月 5 日 as the compliance…Rob Labriola2018 年 5 月 4 日
The Role of a U.S. Agent Blog The Role of a U.S. Agent Foreign sponsors of drug applications who want to conduct business in the United States need…Rob Labriola2016 年 9 月 6 日
Submitting eCTD in Advance of a Milestone Application Blog Submitting eCTD in Advance of a Milestone Application While advanced GPS systems and the advent of Big Data analytics are negating some of…Rob Labriola2016 年 5 月 10 日