Search results for "regulatory agencies" in Articles / App Notes
Article
Regulatory Challenges in the QbD Paradigm
These changes are necessitated by a plethora of issues that are faced by companies and the regulatory agencies alike. The number of blockbuster drugs launched each year has remained relatively constan…
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Early Communication with Regulators is Essential for SMEs
Europe’s regulatory agencies have been stepping up their support for small- and medium-sized enterprises (SMEs), including micro companies, in an effort to stimulate more development of innovative med…
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A Look Ahead at BioPharma Manufacturing and Regulation
FDA currently shares inspection reports, as well as data-systems access, with counterpart national regulatory agencies that often use these reports or inspection findings in lieu of their own inspecti…
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Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
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Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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Successfully Moving Regulated Data to the Cloud
If all of an organization’s data has been collected electronically, this can improve the process of reporting to assist with decision making and generation of submissions to the regulatory agencies.
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Good Manufacturing Practices: Challenges with Compliance
Muzzin (Emergent): It is important to stay abreast of the latest guidance from FDA and other regulatory agencies. To ensure a robust understanding of your product and process, engage early, with speci…
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The Importance of Partnering for Bioanalytical Studies
Additionally, while still in draft form, ICH M10 Bioanalytical Method Validation guidance (3) has been a decade-long collaborative initiative of analytical sciences and regulatory agencies around the …