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FDA: Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, Guidance for Industry

26.02.2015
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs).2 Specifically, this guidance addresses ...

HMA: PSUR Work Sharing and Synchronisation Project

26.02.2015
The PSUR work sharing and synchronisation project was initiated in 2002 under the auspices of the HMA and the European Risk Management Strategy Facilitation Group (ERMS FG). The concept of the ...

RAPS: FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders

26.02.2015
The US Food and Drug Administration (FDA) has announced the release of four guidance documents intended to help increase regulatory oversight of the pharmaceutical compounding industry. The ...

EMA: Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products

19.02.2015
This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) guide. Annex 1 is common to the Member States of the ...

FDA: Individual Patient Expanded Access Applications: Form FDA 3926 Guidance for Industry

19.02.2015
This guidance introduces and describes draft Form FDA 3926 (Individual Patient Expanded 19 Access—Investigational New Drug Application (IND)). When finalized, draft Form FDA 3926 will be ...

FDA: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs Guidance for Industry

19.02.2015
This revised draft guidance provides recommendations on the disclosure of risk information in prescription drug product advertisements and promotional labeling in print media directed toward ...

EFSA: Guidance on the scientific requirements for health claims related to the gastro-intestinal tract, the immune system, and defence against pathogenic microorganisms EFSA Panel on Dietetic Products, Nutrition and Allergies

19.02.2015
The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to revise the guidance on the scientific requirements for health claims related to ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning content of information of February 9, 2015 concerning the entry into force of the Law of December 19, 2014 amending the

19.02.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning content of information of February 9, 2015 ...

GMP: Falsified Results of Analysis at Indian Pharmaceutical Manufacturer

12.02.2015
Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. We recently reported on the unannounced FDA inspections in India as one of the consequences of this ...

EMA: Draft proposal for an addendum, on transparency, to the \'functional specifications for the European Union (EU) portal and EU database to be audited\'

12.02.2015
This consultation document sets out proposals and options on the application of exceptions in relation to the transparency provisions of the European Clinical Trial Regulation. Once finalised, ...

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