Search results for " information"
Article
Global Expansion Shapes Drug Oversight
…pediatric cluster meetings to encourage more common policies for pediatric studies and applications; information exchange by the EMA-FDA pharmacovigilance cluster; and broader cooperation related to …
Article
Challenges in Analytical Method Development and Validation
Using a pre-established set of parameters for method validation may be helpful in expediting the validation process, but it doesn’t necessarily provide relevant information about how the method will p…
Article
Raw Material Variability
Changing to a chemically defined material would be preferred but is not always possible for legacy products where the license has been submitted with detailed raw material and other bioprocess informa…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Techniques of measurement system analysis such as Gage repeatability and reproducibility (Gage R&R) studies are recommended because they provide information on the variability of the measurement syste…
Article
Early Communication with Regulators is Essential for SMEs
…y because of fees reductions and also because companies could make electronic submissions of product information. This year, the rate of increase has slowed down with the total registrations by late …
Article
Climate Change in Outsourcing
Clinical CROs morphed from temporary staffing agencies into information technology innovators as the nature of clinical research changed. Similar shifts are expected to make over the CDMO and CMO indu…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In 2008, the FDA's Office of Biotechnology Products invited companies to participate in a pilot program involving the submission of quality information for biotechnology products in an Expanded Change…
Resource
Parenteral Drug Association
Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise …
Webcast
Accelerate biotech process development
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