Search results for " meeting"
Article
Being Thorough When Transferring Technology
Does the company have the capacity, the equipment, and the capital for the project? If not, is it committed to having a plan in place to meet a client’s timeline while meeting quality and cost expecta…
Article
Drug Quality Key to Innovation and Access
… standards and how written agreements should map out the roles and responsibilities of each party in meeting those goals.
Industry and FDA will face challenges as they continue to implement drug …
Article
Efforts Accelerate to Streamline Postapproval Change Process
The EWG is circulating draft proposals with the aim of reaching consensus on a Step 1 standard at the ICH November 2016 meeting in Japan. If successful, the group anticipates approval of a final stand…
Article
Platform Approach Speeds Process Development
… reliable evidence that process parameters and associated critical product attributes are capable of meeting the anticipated product quality profiles.
Conclusion
With the increasing number of…
Article
Innovative Therapies Require Modern Manufacturing Systems
CDER further aims to encourage manufacturer adoption of cutting-edge pharmaceutical production technology by providing assistance in meeting regulatory requirements for innovative systems. A draft gui…
Article
Biopharma Advances Demand Specialized Expertise
The expanding capacity needs result in partnerships between clients and their contractors with the systems, experience, and expertise to achieve the quality and speed required, while meeting all regul…
Article
Quality Systems Key to Lifecycle Drug Management
An ICH expert working group discussed a Q12 concept paper in Lisbon, Portugal in November 2014, and a more detailed proposal is scheduled for further discussion at the June ICH steering committee meet…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
She reiterated this approach at the February 2015 annual meeting of the Generic Pharmaceutical Association, urging development of continuous manufacturing operations that can achieve consistent produc…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
New Era for Generic Drugs
Specific goals for reviewing ANDAs kick in this year, and manufacturers have concerns about OGD meeting the schedule. An unanticipated problem is that more than 1400 applications were filed this past …