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News & Press: Regulatory Updates

PHSS Aug 2018 Reg Update: EMA identifies gaps in industry prep for Brexit; Field Alert Report

22 August 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update August 2018

 

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU, USA and ICH
regulatory authorities.


The topics covered in this edition of the “Update” include:

 

Europe
Update of EU / Japan 2004 MRA extends scope
EMA identifies gaps in industry preparedness for Brexit
Valsartan (impurity) medicines update
The Process Licensing Office has joined the MHRA Inspectorate
The Responsible Person named on the WDA -Part 2

 

USA
Field Alert Report submission Q&A
Labeling for Biosimilar Products
Indications and usage section of labeling for human prescription drug and biological products
Liquids and/or soft foods as vehicles for drug administration general considerations
FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations (Oncology)
Compounding Laws and Policies

 

International
ICH
ICH prepares for future new topics

 

Products
Ranier’s Rx Laboratory issues voluntary recall of all sterile compounded products



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