reg-info.com
@reg_info Europe
Regulatory intelligence sources for pharmaceutical professionals and others interested in the development of medicines compiled by Tim Felgate
Text follow reg_info to 40404 in the United States
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Improving Medical Treatment Requires a Risk-based Approach to the Regulation of Clinical Trials e-ra.eu/zp98Zm
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EMA: Scientific guideline: Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluat... e-ra.eu/zE4VYk
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Regulatory intelligence for pharma group on LinkedIn reaches 1400 members e-ra.eu/wIYmVZ
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UK Department of Health sets out scope of PiP implant and cosmetic surgery reviews e-ra.eu/xzoaVR
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MHRA letter in response to Lancet articles on regulation of medical devices e-ra.eu/wfv6B5
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EMA: Regulatory and procedural guideline: Qualification of novel methodologies for drug development: guidance t... e-ra.eu/wl71my
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EMA: Draft guideline on the approach to establish a pharmacological acceptable daily intake e-ra.eu/yjzu2U
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MHRA: Pre-consultation questionnaire for the 'Falsified Medicines Directive' (Directive 2011/62/EU) e-ra.eu/zsz8fr
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Empowering the patient: European Commission wants clearer rules for information on prescription medicines e-ra.eu/yMj5jR
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RT @timfelgate: Updating of summaries of product characteristics prompted by changed ATC codes for 2012 e-ra.eu/ynq6qm
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EMA: Scientific guideline: Concept paper on key aspects for the use of pharmacogenomic methodologies in the pha... e-ra.eu/wl1zZe
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EMA: Scientific guideline: Draft guideline on the approach to establish a pharmacological ADI, draft: consultat... e-ra.eu/wsKQ4Y
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EMA: Scientific guideline: Guideline on data requirements for removing the target animal batch safety test for ... e-ra.eu/wfyfpg
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EMA: Scientific guideline: Guideline on statistical principles for clinical trials for veterinary medicinal pro... e-ra.eu/AF4HV0
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EMA: Regulatory and procedural guideline: Initial notices for parallel distribution – December 2011 e-ra.eu/wSgePG
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EMA: Scientific guideline: Guideline on Active Substance Master File Procedure (Rev.3), draft: consultation open e-ra.eu/zjszjT
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EMA: Scientific guideline: Guideline on similar biological medicinal products containing interferon beta, draft... e-ra.eu/wz1Aei
