Article archive

New FDA Guidance for Drug Development Tools

05/02/2014 00:05
The U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry and FDA Staff: "Qualification Process for Drug Development Tools". This guidance describes the process for qualifying drug development tools (DDT). Like for example biomarkers, clinical outcome assessments (COAs),...

Pfizer’s New Breast Cancer Drug Succeeds in Trial

04/02/2014 00:26
Pfizer’s experimental breast cancer drug significantly improved patient survival rates in a mid-stage trial without their condition worsening, maintaining the company’s lead in the race for a new treatment standard for the disease.  Reuters    

Novartis to Cut or Transfer Up to 4,000 Pharma Jobs

04/02/2014 00:23
Novartis plans to cut or transfer up to 4,000 jobs. The plan comes on top of efforts to reduce the number of Novartis’ production sites and is part of a larger cost-cutting push.  BD Live

Eli Lilly provides statement in response to Sanofi US lawsuit

04/02/2014 00:20
Eli Lilly says it does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents.  Pharmaceutical Business Review

GCP and Bioequivalence Studies: new FDA/EMA Initiative

04/02/2014 00:01
Back in 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) implemented an initiative on GCP inspections. Based on the success of this initiative, the scope will now be expanded to include inspections for generic marketing applications. FDA, EMA but also...

MHRA Press release: The British Pharmacopoeia celebrates its 150th birthday

01/02/2014 00:36
Press release: The British Pharmacopoeia celebrates its 150th birthday Summary The authoritative collection of medicinal standards, the British Pharmacopoeia (BP) turns 150 years old this week. The BP has a long and prestigious history which will be celebrated throughout 2014.

New presentation on "Future Activities of ICH from the FDA Point of View"

31/01/2014 00:47
The topic was presented at the Annual DIA Japan meeting on November 7, 2013, by Theresa Mullin, PhD, FDA's director of the Office of Strategic Program, CDER. Dr. Mullin recommended preserving four strengths of ICH on approaching the future:  commitment of significant staff resources,...

USP proposed to Revise the General Chapter <1092> on Dissolution

31/01/2014 00:41
The USP General Chapters - Dosage Forms Expert Committee has proposed to revise General Chapter <1092> The Dissolution Procedure: Development and Validation. The proposed revision will include additional information on:  1) Preliminary assessments needed before initiating procedure...

More Inspections by USFDA in 2014

29/01/2014 23:58
U.S. President Barack Obama has signed the budget for the fiscal 2014 for U.S. Government agencies. With their new budget, The U.S Food and Drug Administration FDA will be able to increase drug plant inspections worldwide and especially in China. The FDA has been given the money which was...

"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications

28/01/2014 23:55
When reviewing submitted applications for authorisation for generics the US Food & Drug Administration (FDA) pays attention to completeness and compliance with certain standards. If the applications do not meet the standards or are even incomplete, the FDA's "Office of Generic Drugs" (OGD)...
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