Christopher A. Fanelli, Author at GoodLifeSci

About Christopher A. Fanelli

Washington, D.C.

Entries by Christopher A. Fanelli

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FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients

January 26, 2024/in Animal Health, FDA, FDA Guidance, GMP, Veterinary Medicines/by Christopher A. Fanelli

FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs.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.

20 06 '23

U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs

June 20, 2023/in Animal Health, FDA, GMP, Regulatory, Veterinary Medicines/by Christopher A. Fanelli

Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.

10 11 '22

Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay

November 10, 2022/in FDA, Regulatory/by Christopher A. Fanelli

Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.

21 06 '22

Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company

June 21, 2022/in ATMP, Cell Therapy, FDA, Gene Therapy, GxP Transactions/by Christopher A. Fanelli

Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when considering an […]

10 06 '22

Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies

June 10, 2022/in ATMP, Cell Therapy, FDA, Gene Therapy, GxP/by Christopher A. Fanelli

Chris Fanelli explains how emerging cellular and gene therapy companies present unique challenges and unique opportunities from a compliance perspective. He explores some of the tools that buyers can use […]

About Christopher A. Fanelli

Entries by Christopher A. Fanelli

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