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FDA: Guidance for Industry CMC Post approval Manufacturing Changes To Be Documented in Annual Reports

10.04.2014
This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. ...

GMP: WHO publishes revised draft on the Guideline on \"Hold Time\" studies

10.04.2014
The key message of the Guideline has remained unchanged: manufacture in compliance with GMP requires the definition of hold times for intermediates and bulk products. The scope stated is the ...

GMP: FDA plans Changes to the Classification of Medical Devices

10.04.2014
At the end of March, the FDA announced in the Federal Register that changes to 21 CFR 860 (Medical Device Classification Procedures) were planned. According to its risk class, a medical device ...

GMP: New FDA Guideline on Size, Shape and Physical Attributes of Generics

10.04.2014
The FDA published a guideline draft entitled \"Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules\". The Agency saw a need for regulation because of the fact that the ...

EMA: The Revised Checking Process of Mock-Ups and Specimens of outer/immediate labelling and package leaflets in the Centralised Procedure for Veterinary Medicinal Products

03.04.2014
The Agency operated an extensive checking process of the Marketing Authorisation Holder’s (MAH) printed materials for outer and immediate labelling of centrally authorised medicinal products as ...

EMA: Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia

03.04.2014
This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic ...

GMP: European Commission publishes Question & Answer Document on GDP

03.04.2014
On 28 March 2014 the European Commission has published a new question and answers document which will clarify some frequent asked questions about the interpretation of the new EU GDP Guideline. ...

EMA: Guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products that contain modified proteins as active substance.

27.03.2014
This guideline outlines the approaches to be followed for declaring the quantitative composition / potency labelling of medicinal products that include modified proteins as their active substance, ...

FDA: Draft Guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

27.03.2014
This guidance is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human prescription drug and biological products for indications that are approved ...

EMA: Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins

27.03.2014
The Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins, CHMP/BMWP/42832/2005 laid down general recommendations for the performance of a systematic immunogenicity ...