Q1. What DMFs incur fees? Only DMFs that cover the manufacture of an API (Type II API DMFs) for...
Archive for category: Regulatory Affairs
Pharmaceutical industry regulation undermines NICE drugs appraisal work – Courtesy (Pharmanews.eu)
Pharma Live, , Regulatory Affairs, 0Government policies that support UK pharmaceutical science and enhance export income are costing the NHS millions and undermine the...
What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
Pharma Live, , Regulatory Affairs, 0Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...
FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations – Courtesy (Hogan Lovells)
Pharma Live, , Regulatory Affairs, 0On 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)
Pharma Live, , Regulatory Affairs, 0The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK...
B. Braun Receives FDA Approval to Offer Broad Spectrum Intravenous Antibiotic-Meropenem, in Its Innovative DUPLEX Container – Courtesy (Market Watch)
Pharma Live, , Regulatory Affairs, 0B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, announced that it received U.S. Food...
Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights – Courtesy (pharmaexec.com)
Pharma Live, , Regulatory Affairs, 0The European Union’s directive on patients’ rights in cross-border healthcare was seen as a bit of a damp squib...
CAPA and Root Cause Analysis – Courtesy (Pharmaceutical Manufacturing)
Pharma Live, , Regulatory Affairs, 0Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do...
Many fixed-dose drug combinations in India lack central regulatory approval – Courtesy (EurekAlert)
Pharma Live, , Regulatory Affairs, 0Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India —...
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in...