ARTICLES BY MICHAEL COOPER

• Certifying Pharmaceutical Exports: A Roadmap To EMA’s Certificate Of Medicinal Product

  In Part 1 of this two-part series, we discussed requirements for exporting U.S.-manufactured material to foreign markets supported by an FDA-issued certificate of pharmaceutical product (CPP). Here in Part 2, we will explain how to export EU-manufactured product to foreign markets leveraging a certificate of medicinal product (CMP) issued by the European Medicines Agency (EMA).

• Certifying Pharma Exports: Intro To FDA’s Certificate Of Pharmaceutical Product

  When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. In Part 1 of a two-part article, we discuss the requirements for exporting U.S.-manufactured material to foreign markets leveraging a certificate of pharmaceutical product (CPP) issued by the FDA. 

• CBER Takes On More Oversight Of Biologic Biosimilar Master Files

  For a new biologic product applying for marketing authorization under a biologics license application (BLA), the drug master file (DMF) may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed in this article.