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GMP: Revision of relevant PIC/S Guidance Documents in 2014

16.04.2015
Amongst the guidance documents of the European Union and of the US authorities, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) published the revisions of two relevant guidance ...

GMP: Mixing, Diluting, or Repackaging Biological Products - FDA Draft Guidance

16.04.2015
In February, the FDA published a new draft guidance on \"Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application\". Background is the ...

GMP: New EU GMP Annex 15 Revision published - Valid as of 1 October 2015

16.04.2015
In February 2014 the draft for the revision of EU GMP Annex 15 was published (see the GMP-News from 11 February 2014 \"Revision of the EU GMP Annex 15 for Qualification and Validation ...

RAPS: Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System

16.04.2015
In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug ...

RAPS: EU Committee Confirms Increased Risk with Ibuprofen at High Doses

16.04.2015
A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient\'s risk for cardiovascular issues. ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 2, 2015 concerning a temporary interruption in the supply of medicinal products: Insuman Rapid, Basal and Comb (human insul

16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 2, 2015 concerning a temporary interruption in the ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 8, 2015 concerning a additional measures taken to minimize the risk of osteonecrosis of the jaw caused by medicines contain

16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 8, 2015 concerning a additional measures taken to ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 15, 2015 concerning a ibuprofen and risk of cardiovascular events large doses of the medicinal product

16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 15, 2015 concerning a ibuprofen and risk of ...

RAPS: Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

02.04.2015
A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be ...

RAPS: EMA Updates its Biosimilar Insulin Guideline

02.04.2015
The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the ...