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FDA Guidance for Industry: Hypertension: Developing Fixed-Combination Drug Products for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. This guidance focuses on development of two-drug combinations of previously approved drugs, although the general approach is readily applicable to three or more drugs in combination. This guidance does not address combinations that include unapproved drug products. [...]

2018-11-12T22:42:01+00:00 13.11.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs

This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic [...]

2018-10-08T10:15:04+00:00 08.10.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

This guidance provides industry with the Food and Drug Administration’s (FDA’s) recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers. Specifically, this guidance provides FDA’s revised definitions for single-dose and multiple-dose containers as well as for the new [...]

2018-10-07T18:02:24+00:00 08.10.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This guidance is intended for firms that have registered with the Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content [...]

2018-10-04T19:42:04+00:00 04.10.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a [...]

2018-09-24T18:45:41+00:00 25.09.2018|Regulatory Affairs, Training|

EMA: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate – Revision 1

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise [...]

2018-09-19T22:34:35+00:00 19.09.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Nonallergic Rhinitis: Developing Drug Products for Treatment

The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. The guidance discusses issues regarding the definition of a clinical phenotype, trial design, efficacy, and safety for new drug products under development. In particular, the guidance addresses development [...]

2018-09-09T11:00:12+00:00 09.09.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Allergic Rhinitis: Developing Drug Products for Treatment

The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The recommendations in this guidance are [...]

2018-09-09T10:54:48+00:00 09.09.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Physiologically Based Pharmacokinetic Analyses — Format and Content

This guidance outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to the FDA to support applications including, but not limited to, investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). To enable efficient and consistent review, the FDA recommends [...]

2018-09-06T22:27:15+00:00 07.09.2018|Regulatory Affairs, Training|

EMA: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to [...]

2018-08-20T22:22:52+00:00 21.08.2018|Regulatory Affairs, Training|

EMA: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) – Revision 1

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005   Posted on the EMA website on 15 August 2018

2018-08-16T11:22:03+00:00 16.08.2018|Regulatory Affairs, Training|

EMA: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory [...]

2018-08-08T15:08:23+00:00 08.08.2018|Training|

EMA: Draft questions and answers on Data Monitoring Committees issues

The aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee Guideline (Doc Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle as well as with regard to the responsibilities for implementing DMC decisions. [...]

2018-08-05T14:02:35+00:00 06.08.2018|Regulatory Affairs, Training|

EMA: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.   Posted on the [...]

2018-08-05T13:00:19+00:00 05.08.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: E17 General Principles for Planning and Design of Multiregional Clinical Trials

With the increasing globalization of drug development, it has become important that data from multiregional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and countries as the primary source of evidence to support marketing approval of drugs (medicinal products). The purpose of this guidance is to describe general principles for the planning and design of MRCTs [...]

2018-07-24T22:06:58+00:00 24.07.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Labeling for Biosimilar Products

This guidance is intended to help applicants develop draft labeling for proposed biosimilar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations [...]

2018-07-24T22:00:38+00:00 24.07.2018|Regulatory Affairs, Training|

EMA: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.   Posted on the EMA website on 9 July [...]

2018-07-09T22:49:12+00:00 10.07.2018|Regulatory Affairs, Training|

EMA: Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure

This list of Questions and Answers (Q&As) complements the Notice to marketing authorisation holders of centrally authorised medicines products for human and veterinary use, which was updated on 23 January 2018.   This list of Q&As has been drafted jointly by the Directorate-General for Health and Food Safety of the European Commission and EMA. This version [...]

2018-06-19T21:42:46+00:00 20.06.2018|Regulatory Affairs, Training|

EMA: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders (MAHs) of centrally authorised medicines products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means [...]

2018-06-19T21:36:17+00:00 20.06.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers

Since the ICH guidance S9 Nonclinical Evaluation for Anticancer Pharmaceuticals was finalized (ICH S9 or ICH S9 guidance), all parties using the guidance have experienced some challenges with implementation of the recommendations on nonclinical evaluation for anticancer pharmaceuticals. This question-and-answer guidance is intended to facilitate the implementation of ICH S9, as well as to continue progress in the 3Rs [...]

2018-06-19T21:07:16+00:00 19.06.2018|Regulatory Affairs, Training|