Entries by Dr. Chris Boyle

19 03 '24

EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises

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On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.

26 01 '24

FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients

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FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs. Following a consultation period, it is also expected to be implemented in Japan, the EU, and the UK. Chris Fanelli, Dr. Chris Boyle, and Dan Roberts discuss what the new guidance means for animal drug manufacturers.