Search results for " FDA" in Articles / App Notes
Article
Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
Article
Prepare for an FDA Bioburden Inspection
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.
Article
Prepare for an FDA Bioburden Inspection
A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help improve processes and procedures. Anastasia Lolas, former FDA …
Article
FDA Urged to Preserve Biosimilar Naming Conventions
In a letter to FDA, NCPDP cited operational problems with the implementation of a system other than the current INN system and stated concerns about what kind of impact that a change in system would h…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
In October 2010, FDA issued a framework for advancing regulatory science for public health, which focused on the following: accelerating delivery of new medical treatments; improving pediatric and chi…
Article
Driving Improved Access to Biosimilars
In a formal statement in December 2018 (2), former FDA commissioner Scott Gottlieb referred to insulin prices, which have increased nearly 600% between 2001 and 2015, with the average US list price ri…
Article
Regulatory Challenges in the QbD Paradigm
It's no wonder that "Supply Chain Management," "Accountability in a Global Environment," "Foreign Inspections," and "International Compliance" were some of the key sessions at the 2011 PDA/ FDA Joint …
Article
Innovative Therapies Require Modern Manufacturing Systems
More biosimilars are poised to come to market in 2016 following FDA approval of the first such therapy in 2015. At the same time, though, the development of such innovative and targeted therapies heig…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
An FDA advisory committee voted unanimously to recommend approval of Novartis’ new CAR-T, despite concerns about the firm’s ability to process patient T-cells consistently and safely (1). Similar issu…
Article
Biopharma Seeks Balance
To increase the potential for approval, companies need to provide better “packages” that describe how the drug works, said Scott Gottlieb, FDA commissioner, at the 2018 BIO convention in Boston on Jun…