Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients
-
US FDA issues draft norms on waiver of in-vivo BA & BE studies for subsequent analysis; pharma cos to save time, cost – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0
The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
-
What Is the Industry Underestimating About An ADC Supply Chain? – Part 2 – Courtesy (pharmaceutical Online)
Pharma Live, , Regulatory Affairs, 0
In What Is the Industry Underestimating About An ADC Supply Chain? – Part 1, I spoke with industry experts from...
-
A science based approach to topical drug classification system (TCS) – Courtesy of Science Direct
Pharma Live, , Regulatory Affairs, 0
The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in...
-
Root Cause Analysis (RCA)
Pharma Live, , Regulatory Affairs, 0
Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
-
CAPA and Root Cause Analysis – Courtesy (Pharmaceutical Manufacturing)
Pharma Live, , Regulatory Affairs, 0
Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do...
-
Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent – Courtesy(Pharma Patents)
Pharma Live, , Regulatory Affairs, 0
POSTED BY COURTENAY C. BRINCKERHOFF ON 3 NOVEMBER 2011POSTED IN FEDERAL CIRCUIT DECISIONS;PATENT TERM EXTENSIONI wrote previously about the patentability issues raised in Genetics Institute,...
-
Janssen’s Fruitful Continuous Manufacturing Collaboration
Pharma Live, , Regulatory Affairs, 0
Janssen Supply Chain, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has a long-standing collaborative partnership...
-
Scottish cost regulators OK NHS use of 7 new drugs – Courtesy (Pharma Times)
Pharma Live, , Regulatory Affairs, 0
The Scottish Medicines Consortium has approved seven new medicines for use on NHS Scotland, including the first biologic treatment...
![](https://interactivepharm.com/wp-content/uploads/2022/08/Show-your.jpg)