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Electronic Submissions Presentations by USFDA

11/05/2014 13:51
Electronic Submissions Presentations FDA/CDER Small Business and Industry Assistance (CDER SBIA) GDUFA and You Conference 2014 March 27, 2014 Optimizing your eCTD ANDA, Jared Lantzy, PMP, Data Management Solutions Team, Office of Business Informatics, CDER

Allergen Manufacturer Warned for Unapproved Drugs, Insect Infestation

11/05/2014 13:37
  The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. The warning letter, released by the agency Tuesday, is a follow-up to a Form 483...

New Rules for Clinical Trials conducted in the EU- Questions & Answers

11/05/2014 13:27
Following the positive vote in Parliament for the new Clinical Trial Regulation, the EU Commission has published a set of Q&Ason clinical trials. Here it is also discussed why the current legislation is being replaced and the main changes are summarised: The new authorisation...

Draft Guideline on Validation of biotechnology-derived Products by EMA

11/05/2014 13:23
For the EMA, it was necessary to develop an independent guideline on the topic as - despite the existence of harmonised ICH documents - specific aspects of the validation of biotechnology-derived products have been missing. A draft is now available.  With 11 pages, the document entitled...

New USP Proposal for Optimised Method of Measuring Moisture Vapour Permeation related to Pharmaceutical Packaging

30/04/2014 17:24
A "Stimuli to the Revision Process" article has been published in the Pharmacopoeial Forum 40(2) to propose a new method for measuring moisture vapour permeation.  The article is based on a workshop organised by the USP together with the Product Quality Research Institute (PQRI) last...

Revision of the USP Chapter on Spectroscopic Methods

30/04/2014 17:21
In the USP Pharmacopeial Forum 40(1), a "Stimuli to the Revision Process" article states that the responsible working group of the USP has conducted a review of the existing general chapters on spectroscopic methods.  The goal of this review was to establish a uniform concept for all the...

New FDA Guidance to Avoid Overfill of Vials

23/04/2014 17:57
If a liquid is withdrawn from a vial by means of a syringe, remains of the liquid stay in the vial or on its walls. Since it is nearly impossible to extract 100 % of the liquid but the dosage has to be correct, nevertheless, vials usually are slightly overfilled. A vial with a dosage of 1 ml...

FDA wants to increase Number of foreign Inspections

23/04/2014 17:51
In its proposed fiscal 2015 budget, the U.S. Food and Drug Administration FDA details the plans for their inspections in the new fiscal year. The agency would like to perform approx. 20 percent more foreign GMP inspections, from 827 in the year 2013 up to 999 in 2014 and 2015. The companies will be...

EMA: Changes to Handling of Variations

23/04/2014 17:49
Because of the ongoing reorganisation of the European Medicines Agency (EMA), new operating procedures will apply for: Type IA and IB variations; Type II variations; Periodic Safety Update Reports (PSURs); Administrative procedures such as transfers, 61(3) notifications and corrigenda. The...

Another FDA Import Alert for an Indian Manufacturer due to GMP problems

23/04/2014 17:43
The FDA has issued an Import Alert for an Indian manufacturer due to serious GMP deviations. Apotex Pharmachem in India Plot No.: 1A, Bommasandra , Industrial Area, 4th Phase , Bangalore was found out of GMP compliance. As a result of the FDA Import Alert no products covered by the Import...
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