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EMA: Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance

10.08.2016
This document provides product-specific guidance on the demonstration of the bioequivalence of vandetanib. ...

EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)

10.08.2016
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent ...

EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)

10.08.2016
Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal ...

EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

10.08.2016
Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal ...

FDA: Ulcerative Colitis: Clinical Trial Endpoints

10.08.2016
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance ...

GMP: WHO publishes Draft of an Umbrella Guideline on Process Validation

20.07.2016
At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO ...

GMP: FDA issues new Draft Guidance on Elemental Impurities

20.07.2016
The ICH Q3D \"Guideline for Elemental Impurities\" was issued in December 2014 and recommended for adoption in the regulations portfolio of the ICH regions Europe, USA and Japan according to the ...

GMP: FDA Draft Guidance on Critical Quality Attributes for Chewable Tablets

20.07.2016
On June 16, 2016, the US Food and Drug Administration, FDA, published a draft guidance on \"Quality attribute considerations for chewable tablets\". Comments and suggestions regarding this draft ...

FDA: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

20.07.2016
For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), it must not be ...

FDA: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

20.07.2016
To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), a drug product must be compounded by a licensed pharmacist or physician who does not ...

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