Search Results for Draft Guideline

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Reproductive Toxicity: FDA Consults on Revised ICH Guideline By Michael Mezher - Published 09 November 2017

The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Reproductive Toxicity, ICH, S5(R3), Draft Guideline

EMA Consults on Revised Factor VIII Product Guidelines By Michael Mezher - Published 30 October 2017

The European Medicines Agency (EMA) on Monday issued two draft revised guidelines on plasma-derived and recombinant coagulation factor VIII products that remove requirements for conducting clinical studies in previously untreated patients (PUPs).

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical

Tags: Hemophilia, Factor VIII, Draft Guideline

EMA Issues New Guideline on Controlling Disease Transmission Risks in Urine-Based Products By Alexander Gaffney, RF News Editor - Published 26 November 2013

Categories: EMA

Tags: Urine, Draft Guideline, Latest News, EU

EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines By Alexander Gaffney, RF News Editor - Published 29 May 2013

Categories: EMA

Tags: Antimicrobial, antibiotics, Draft Guideline, Latest News, guideline, EU

New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies By Alexander Gaffney, RF News Editor - Published 02 May 2013

Categories: EMA

Tags: Biosimilarity, Draft Guideline, Latest News, follow-on biologic, biologic, biosimilar, EU

EMA Publishes New Lupus Guideline Intended to Spur Development of New Therapies By Alexander Gaffney, RF News Editor - Published 06 March 2013

Categories: EMA

Tags: Lupus, Clinical Research, Draft Guideline, Latest News, clinical trials

UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B By Louise Zornoza, RegLink - Published 18 January 2013

Categories: Regulatory Update, NICE

Tags: Draft Guideline, NHS, Hepatitis B, guideline

NICE Draft Guidance Recommends Drugs Not Indicated for Familial Breast Cancer By Louise Zornoza, RegLink - Published 16 January 2013

Categories: NICE

Tags: GMC, Breast Cancer, Draft Guideline, Latest News, UK

India Issues Draft Drug GDP Guidance By Ansis Helmanis, RegLink - Published 14 January 2013

Categories: Regulatory Update, India, CDSCO, Distribution

Tags: Good Distribution Practices, GDP, Draft Guideline

India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines By Alexander Gaffney, RF News Editor - Published 01 November 2012

Categories: India, CDSCO

Tags: Draft Guideline, Latest News, guideline, recalls

EMA Releases Draft Guideline on Acute Heart Failure Therapies By Alexander Gaffney, RF News Editor - Published 15 October 2012

Categories: EMA

Tags: Chronic Heart Failure, Acute Heart Failure, Heart Failure, AHF, Draft Guideline, Latest News, guideline

EMA Draft Guidance Adds Testing Requirements for Manufacturers of Bovine Serum By Alexander Gaffney - Published 01 October 2012

Categories: EMA

Tags: Bovine Serum, BVDV, TSE, Draft Guideline, Latest News, BSE, guideline

Draft Guideline on Labeling Immunoglobulin Products Released by EMA By Alexander Gaffney - Published 31 July 2012

Categories: EMA

Tags: Immunoglobulin, SmPC, Draft Guideline, Latest News

EMA Releases New Draft Guideline on Ensuring the Quality of Animal-based Biotechnology By Alexander Gaffney - Published 31 May 2012

Categories: EMA

Tags: Transgenic, Transgenesis, Biotechnology, Draft Guideline, Animals, Latest News

EMA Releases Draft Guideline on Process Validation By Alexander Gaffney - Published 13 April 2012

Categories: EMA, ICH

Tags: Continuous Process Validation, Draft Guideline, Latest News, process validation

Draft Guideline Released on Assessing Risk of Advanced Therapy Medicinal Products in Europe By Alexander Gaffney - Published 24 January 2012

Categories: EMA

Tags: Risk-based Approach, Draft Guideline, Advanced Therapy Medicinal Products, ATMP, Latest News, risk