-
FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations – Courtesy (Hogan Lovells)
On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed...
-
Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions – Courtesy (The SPC Blog)
The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK...
-
A REVIEW ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS
ABOUT AUTHORS:Vikash Kumar Chaudhari1*, Vijay Yadav2, Praveen Kumar Verma1, Amit Kumar Singh21Department of Pharmaceutical Chemistry,2Department of Pharmacognosy,Kunwar Haribansh Singh...
-
-
Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
1-s2-0-s0169409x07003195-main-1Download
-
What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...
-
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)
The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
-
CAPA and Root Cause Analysis – Courtesy (Pharmaceutical Manufacturing)
Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do...
