FDA: Guidance for Industry: Stability Testing of Drug Substances and Products, Questions and Answers

This guidance provides answers to questions from the public comments we received on the draft guidance for industry on NDAs: Stability Testing of Drug Substances and Products (FDA stability ...

EMA: Draft guideline on non-clinical local tolerance testing of medicinal products

Local tolerance testing is intended to support human exposure to a medicinal product (both active substance and excipient) at contact sites of the body following clinical use. ...

EMA: Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues (Rev 2)

This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), ...

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

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

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

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

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

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

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

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 ...

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