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EMA: Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2)

20.08.2015
A post-authorisation safety study (PASS) is defined in Directive 2001/83/EC (DIR) Art 1(15) as any study relating to an authorised medicinal product conducted with the aim of identifying, ...

EMA: Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2)

20.08.2015
This addendum specifies requirements for the transmission of study protocols, updated protocols following substantial amendments, final study reports and progress reports if requested on ...

EMA: Guideline for good clinical practice E6(R2) 4 - Step 2b

13.08.2015
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. ...

EMA: Draft guideline on the processing of renewals in the centralised procedure

13.08.2015
This guideline considers issues associated with the processing of renewals in the centralised procedure, with an aim of giving procedural guidance to marketing authorisation holders (MAHs). It has ...

FDA: Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs

13.08.2015
This guidance is developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/or abbreviated new drug ...

FDA: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen

13.08.2015
This guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription also ...

RAPS: EMA Updates Two Pharmacovigilance Guidelines

13.08.2015
Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU.The two guidelines include a draft ...

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 ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 7, 2015 concerning the publication of updated guidelines on the labeling of packaging of medicinal products registered in

13.08.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 7, 2015 concerning the publication of updated ...

EMA: Draft qualification opinion total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)

06.08.2015
The Critical Path Institute’s Polycystic Kidney Disease Outcome Consortium (PKDOC) intends to qualify Total Kidney Volume (TKV) as a prognostic biomarker (i.e. predictive for the outcome with ...