Search results for " approval"
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
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FDA Seeks Metrics to Define Drug Quality
To move more breakthrough drugs quickly through the approval process, pharmaceutical and biotech companies need to establish high quality production systems early in development. These imperatives put…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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A Look Ahead at BioPharma Manufacturing and Regulation
This can also facilitate the development and approval of generics with complex dosage forms as well as inform control strategies for quality of complex originator products.
MICROBIAL …
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Quality by design for biotechnology products—part 1
… products, and benefit from a more flexible reporting mechanism for changes to the application after approval. This situation is expected to provide an opportunity for manufacturing to incorporate ne…
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Address the complexity of protein characterization
Since the FDA approved the first monoclonal based therapy in 1985, mAbs have had significant clinical success and have been used to provide effective treatment for a range of diseases. Durin…
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Reviewing the Importance of Biosimilarity and Interchangeability
These studies are essential for the regulatory approval of biosimilars and for ensuring their safe and effective use in clinical practice,” Stamm concludes.
Reference
1. Mirasol, F. Moving Bio…
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Digitalization: The Route to Biopharma 4.0
…roperties of these technologies along with the protocols that need to be followed for validation and approval. This will bring clarity to the manufacturers and aid adoption.
References
1. Zho…
Article
What is process development?
This is especially true if you’re working on a biomolecule and indication that regulators might grant an accelerated pathway to approval. By making key decisions early around process development, qual…