FDA: Size of Beads in Drug Products Labeled for Sprinkle

This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and ...

EMA: Scientific guideline: Draft template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”, draft

The objective of this Qualified Person (QP) Declaration Template is to emphasise the importance of providing a comprehensive declaration, to harmonise the format for the declaration, to forestall ...

EMA: Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP)

Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP) - number of CD and paper copies ...

EMA: Scientific guideline: Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available, draft:

This paper describes regulatory considerations, and expectations of applicants, in discussing the importance of a direct comparison to active control for a properly informed decision on ...

MHRA: Medicines for children: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures

In November 2010, the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published three more paediatric assessment reports following completion of Article 45 ...

FDA: Electronic Source Documentation in Clinical Investigations

This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in ...

FDA: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. FDA ...

EMA; Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work

In accordance with Directive 2004/24/EC (1), amending as regards traditional herbal medicinal products, Directive 2001/83/EC, it is the task of the Committee on Herbal Medicinal Products (HMPC) to ...

EMA: Glossary on herbal teas

The purpose of this paper is to define the terms applied to the preparation of herbal teas by patients. The definitions will help to clarify the terms used to describe the preparation of herbal ...

EMA: Scientific guideline: Reflection paper on the level of purification of extracts to be considered as herbal preparations

This reflection paper applies to extracts used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for ...

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