Search results for " approval"
Article
Efforts Accelerate to Streamline Postapproval Change Process
With more breakthrough and critical therapies gaining fast approval based on limited data and manufacturing experience, more postapproval changes are needed to increase batch size, shift to a new manu…
Article
Breakthrough Drugs Raise Development and Production Challenges
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA program to expedite the development and approval of innovative drugs for serious and life-threat…
Article
Manufacturers Struggle with Breakthrough Drug Development
New approvals in 2013 included three therapies identified as breakthroughs, an impressive payout for a new and complex program. It’s a sign of strong industry interest in developing new drugs with acc…
Article
Early Communication with Regulators is Essential for SMEs
…ion, and above all, scientific advice that can raise the chances of a new medicine gaining marketing approval.
The importance of early dialogue with regulators
Companies are encoura…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
…diversity of efficacy trials and key analytical assessments needed to gain EUA status and later full approval, establishing standards and procedures that will shape research for health emergencies to…
Article
An Analytical Approach to Biosimilar Drug Development
…porting from characterization and comparability studies that are needed for innovator and biosimilar approvals (2).
BioPharm International spoke to Patricia Hurley, PhD, senior director, Reg…
Article
Transformative Medicines Challenge FDA and Manufacturers
Recent months have witnessed the emergence of truly breakthrough therapies, led by Novartis’ CAR-T therapy Kymriah (tisagenlecleucel) for patients with relapsed acute lymphoblastic leukemia; this appr…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
As of February 2017, FDA lists 68 approved mAbs, and approvals have been increasing each year since the late 1990s (3). mAbs are comprised of several domains that contribute to their function. The Fab…
Article
Vaccine Development and Production Challenges Manufacturers
The first draft of the US House of Representatives “21st Century Cures” initiative includes actions to speed up vaccine approval and coverage. Proposals seek to tighten timelines for the Centers for D…
Article
New Era for Generic Drugs
… the Generic Drug User Fee Act (GDUFA), the fee scheme approved by Congress in 2012 to speed up ANDA approvals. The program expands FDA review staff, supports timely field inspections, and funds rese…