|
Abstract:
|
Data Integrity Compliance with GMP and FDA Requirements, 7p. |
|
Abstract:
|
FDA is Not Playing Games with Biosimilars, 1p. |
|
Abstract:
|
FDA Seeks to Revive Quality Metrics Initiative, 2p. |
|
Abstract:
|
Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification, 4p. |
|
Article:
|
Addressing the knowledge gap |
|
Article:
|
Bioprocessing Facilities and FDA Inspection Problems |
|
Article:
|
Expediting a COVID-19 Vaccine: FDA Approval Process |
|
Article:
|
FDA Advances New Approach to Drug Quality Assessment |
|
Article:
|
FDA cGMP Inspections Amid COVID-19 Pandemic |
|
Article:
|
Navigating Uncharted Waters. Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions. |
|
Article:
|
Pharma Facilities Still Have a Lot to Learn |
|
Article:
|
The Recall Effect,
How the blood pressure debacle is rippling through the industry |
|
Article:
|
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021 |
|
Article:
|
Why Dread Your Next FDA Inspection?, 3p. |
|
Insights:
|
McIlvaine Insights Issue 122, October 15, 2019 |
