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EMA: Draft European Union individual case safety report (ICSR) implementation guide

08.05.2014
This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs ...

EMA: Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies

08.05.2014
Neoadjuvant chemotherapy is commonly used in locally advanced breast cancer (LABC) patients to facilitate breast conserving surgery. Currently, disease-free survival (DFS) is considered to be an ...

EMA: Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

08.05.2014
Guidance is provided on data requirements for process validation of biotechnology-derived proteins used as active substance in the manufacture of medicinal products. This guideline covers process ...

GMP: Clinical Trials Regulation adopted in Parliament

08.05.2014
The new EU Clinical Trials Regulation has recently passed the EU Parliament. The objective of the new document was to simplify the authorisation procedures for multinational clinical trials. ...

EMA: EMA guidance for companies requesting classification as MUMS/limited market

24.04.2014
This guidance document addresses a number of questions that applicants requesting classification of products for minor use or minor species (MUMS) or for limited market may have. The Committee for ...

EMA: Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products

24.04.2014
This concept paper addresses the need for a revision of the guidance on the selection of sterilisation methods currently provided for in the annexes to the (separate) human and veterinary ...

EMA: Guideline on stability testing for applications for variations to a marketing authorisation

24.04.2014
This guideline provides guidance on the stability data which have to be generated in order to support a variation to a marketingnauthorisation. The guideline provides general guidance on stability ...

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. ...