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Registration of medicines in the USA – review of opportunities and advice from a former FDA employee

• Basic regulatory documents and business recommendations issued by the FDA and ICH;
• Requirements to innovative drugs;
• Peculiarities of registration of new biotechnological products;
• Peculiarities of registration of generics and bio-analogs;
• Accelerated registration programs offered by the FDA for severe diseases.


Dmitry Kryndushkin

Skolkovo Intellectual Property Center, LLC