FDA and CMS Form Task Force on LDT Quality Requirements
17/04/2015 22:35
FDA and CMS Form Task Force on LDT Quality Requirements
Article archive
U.S. Marshals seize unapproved drugs from Florida distributor
17/04/2015 22:31
U.S. Marshals seize unapproved drugs from Florida distributor
FDA's New Pharmaceutical Quality Approach- One Quality Voice
17/04/2015 22:11
The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory...
Health Canada Launched New Drug and Product Inspections Database
16/04/2015 23:30
Minister Ambrose Launched New Drug and Health Product Inspections Database, UnderlinesCommitment to TransparencySearchabletool makes it easy to find details on inspections of drug companiesApril13, 2015 - Ottawa, ON - Health CanadaHealthMinister Rona Ambrose launched the Drugand Health Product...
TGA finalised the specificationfor the Australian eCTD format submissions
16/04/2015 23:25
The Australian TherapeuticGoods Administration (TGA) has released, on 14 April 2015, the first final specification for the Australian eCTD. Since late 2014 the TGA wasaccepting eCTD submissions based on draft specification 0.9 in a pilot phase to assess the eCTD readiness of the agency and industry...
WHO Called for Increased Transparency in Medical Research
16/04/2015 22:34
14 APRIL 2015 ' GENEVA - WHO issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever theresult. The move aims to ensure that decisions related to the safety andefficacy of vaccines, drugs and medical devices for use by populations...
Indian Government to amend SCHEDULE Y of D&C Rules pertaining to authenticity of data submitted by applicants
16/04/2015 21:38
The Union HealthMinistry will soon amend the Note under Schedule Y (REQUIREMENTSAND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FORSALE OR TO UNDERTAKE CLINICAL TRIALS) of the Drugs and CosmeticsRules, 1945 regarding the authenticity of the data or documents submitted...
FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme
16/04/2015 21:21
Product marketed as a dietary supplement contains potentially harmful synthetic steroids April 13, 2015 The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.Tri-Methyl Xtreme, distributed by Las...
Final EU GMP Annex 15 Qualification & Validation- Effective from 01 October 2015
03/04/2015 00:09
"On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015.
In this article, the changes between the draft version and the revised Annex 15 version are discussed. When the draft was released, there was a...
GMP Pre-Inspection Compliance Documents published by MHRA
03/04/2015 00:06
The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. The MHRA has established a system in which companies have to fill out documents about their current compliance status. These documents are intended to help MHRA...
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