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EFSA: Public consultation on the draft scientific opinion on dietary reference values for vitamin D

04.04.2016
EFSA has launched an open consultation on its draft scientific opinion on dietary reference values for vitamin D. This document proposes dietary reference values for vitamin D for adults, infants ...

RAPS: India Releases New Biosimilars Guidance

04.04.2016
India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India\'s ...

RAPS: FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling

04.04.2016
The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 15, 2015 on the abolition of the requirement of payment of fees for the notification referred to in Article 58 paragraph 3

04.04.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 15, 2015 on the abolition of the requirement of ...

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discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the ...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

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