Can I read FDA Response to Citizen Petitions on Antibiotics on EtoBox?

FDA Response to Citizen Petitions on Antibiotics is a document available to read on EtoBox.

What is FDA Response to Citizen Petitions on Antibiotics about?

This letter responds to four citizen petitions regarding the applicability of the 30-month stay provision to ANDAs for certain old antibiotics. The FDA determined that under the QI Act, no 30-month stay will apply to an ANDA for an old antibiotic based on a paragraph IV certification to a later-listed patent, where the NDA holder has sued the ANDA applicant for infringement. A 30-month stay would still apply if the paragraph IV certification was to a patent listed before the ANDA was submitted. The letter p

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