EMA: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...

FDA: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format - draft guidance

This guidance is intended to assist applicants in preparing the Clinical Pharmacology section of product labeling to meet regulatory requirements and ensure appropriate consistency in the format ...

FDA: Guidance for industry: Immunogenicity Assessment for Therapeutic Protein Product

This guidance is intended to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. In this document, FDA outlines and ...

RAPS: Are New Policies Needed to Help Regulate Generic Drugs? FDA Wants to Know

US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that ...

EMA: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

Since February 2007 the European Medicines Agency (EMA) has been operating an extensive checking process of the marketing-authorisation holder’s (MAH) printed packaging materials for outer and ...

FDA: Upper Facial Lines: Developing Botulinum Toxin Drug Products

The purpose of this guidance is to assist sponsors in the clinical development of therapeutic biological products, specifically botulinum toxins, for the temporary improvement in the appearance of ...

EMA: EMA publishes Document on the Validation of analytical Methods

The European Medicines Agency (EMA) published the concept paper \"Transferring quality control methods validated in collaborative trials to a product/laboratory specific context\". To accept a ...

GMP: Serious GMP Violations found at Chinese API Manufacturer - Basic GMP principles not followed

On 7 July 2014 the US FDA has issued a Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co., Ltd. located in Taizhou, Zhejiang Province in China. The company is a producer of APIs and failed to ...

RAPS: FDA Revises Labeling Guidance to Clarify Clinical Pharmacology Recommendation

A new draft guidance document published by the US Food and Drug Administration (FDA) seeks to help sponsors with the \"clinical pharmacology\" sections that accompany an approved drug\'s labeling. ...

EMA: Draft reflection paper on classification of advanced-therapy medicinal products

This reflection paper has been updated to reflect the current thinking of the Committee on Advanced Therapies (CAT) on substantial manipulation and non-homologous use. Additional changes have been ...

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