Health (Pharmaceuticals – Generic)

 

• Consultation for accelerated market entry strategies regarding generic active pharmaceutical ingredient (API) drugs such as the use of abbreviated new drug applications (ANDAs), ANDA suitability petitions (a request to the FDA to permit filing an ANDA for a new drug that differs from the reference listed drug – RLD – requiring an approved suitability petition before an ANDA may be filed, specifying the proposed differences) or 505(b)(2) new drug applications (NDAs).

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• Consultation for legal strategies regarding how to commercialize generic drugs under the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act (FD&C Act).

 

    Last updated 210509_1521