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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 30, 2015 on the the fulfillment by responsible entities from the obligation referred to in Article 24 paragraph 1 point 4 l

04.04.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 30, 2015 on the the fulfillment by responsible ...

FDA: Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations

25.03.2016
This guidance is intended to help sponsors determine the amount and types of safety data to collect during late-stage premarket and postapproval clinical investigations, (e.g., phase 3 clinical ...

FDA: Immunogenicity-Related Considerations for Low Molecular Weight Heparin

25.03.2016
This guidance discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the ...

RAPS: FDA: Generic Opioids Must be \'No Less\' Abuse-Deterrent Than Brand-Name Versions

25.03.2016
The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their ...

GMP: New FDA Guidance on Extent of Safety Data in Late Stage and Postapproval Clinical Investigations

25.03.2016
On February 18, 2016, the U.S. Food and Drug Administration, FDA, published a new Guidance for Industry on \"Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and ...

EMA: Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016

14.03.2016
The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on ...

EMA: New treatment for advanced form of kidney cancer

14.03.2016
The European Medicines Agency (EMA) has recommended extending the use of Opdivo (nivolumab) to include the treatment of adult patients with advanced renal cell carcinoma (a type of kidney cancer) ...

EMA: Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format

14.03.2016
The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the ...

EC: Pharmacovigilance - Major developments

14.03.2016
As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for ...

EMA: Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias

17.02.2016
This guideline replaces \'Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1). ...