Search results for " FDA guidance"

Article Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers New gene therapies and combination products require innovative regulatory approaches. By Jill Wechsler …

Article FDA Approves First Biosimilar
Mar 06, 2015 By Randi Hernandez BioPharm International FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…

Article FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies. By Cynthia A. Challener Ibreakstock/Shutterstock.co…

Article FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages. Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…

Article FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…

Article Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…

Article FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies More consistent and reliable production processes are critical for advancing innovative treatments. By Jill Wechsler …

Article Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015 By Jill Wechsler Pharmaceutical Technology Volume 39, Issue 4 To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…

Article FDA Lists Guidance Documents Planned for 2013
FDA has released a list of more than 50 guidance documents planned for 2013. The list reflects guidance documents currently under development as of the date of the posting, Jan. 31, 2013. Planned do…

Article Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA. By Siegfried Schmitt Q: We are a contract manufacturing organization (CMO), sp…

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