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GMP: GMP Non Compliance Reports - Update in EMA Database

24.04.2014
The EMA Database EudraGMDP is a major achievement for GMP and GDP compliance information. Since parts of the data are now publicly accessible, it makes it easier to get important information ...

FDA: Guidance - Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations

24.04.2014
The purpose of this guidance is to describe the Agency’s current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and its ...

FDA: Guidance for Industry Immunogenicity - Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs

10.04.2014
This draft guidance discusses immunogenicity - related approval considerations for low molecular weight heparin (LMWH) products. ...

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. ...

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