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Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines

07.12.2016
Guidance reflects European Commission’s notice on the application of the Orphan Regulation The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of ...

EMA: Promoting high-quality clinical research to develop more and better medicines for children

19.04.2016
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its 8th annual workshop on 2 June 2016 at the premises of the European Medicines Agency (EMA) in ...

RAPS: FDA Approves First Drug to Improve Overall Survival in Liposarcoma

29.01.2016
FDA Approves First Drug to Improve Overall Survival in Liposarcoma The US Food and Drug Administration (FDA) on Thursday approved a new indication for Eisai\'s Halaven (eribulin mesylate) to ...

RAPS: Proposed Rule Would Revise Regulations on Fixed-Combination Drugs

29.12.2015
The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and ...

EMA: Draft qualification opinion on the paediatric ulcerative colitis activity index (PUCAI)

21.09.2015
The paediatric ulcerative colitis activity index (PUCAI) measures disease activity in pediatric ulcerative colitis (Turner D. et al., 2007). It was developed to act as an accurate non-invasive ...

RAPS: New FDA Guidance Addresses Common Issues in Orphan Drug Development

04.09.2015
The US Food and Drug Administration (FDA) has released a draft guidance intended to help drugmakers tackle common issues encountered in the development of drugs to treat rare diseases. ...

FDA: Rare Diseases: Common Issues in Drug Development

20.08.2015
This guidance assists sponsors of drug and biological products intended to treat or prevent rare diseases in conducting more efficient and successful development programs through a discussion of ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 4, 2015 concerning stimulating the development of medicines for children

13.08.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 4, 2015 concerning stimulating the development of ...

EMA: Stimulating the development of medicines for children

23.07.2015
EMA’s revision of class waiver list expected to push the exploration of many more medicines for use in children The European Medicines Agency’s Paediatric Committee (PDCO) has revised the ...

EMA: EMA recommends treatment for rare cancer in children

28.05.2015
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma, a type of cancer that most often ...