Recently Posted Guidance Documents on User fees, Generic Drugs, Safety, and Clinical - Antimicrobial

User Fees 10/13/2017 Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA 10/12/2017  Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry 10/11/2017  Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry Generic Drugs 10/11/2017 Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry Safety 10/11/2017  Format and Content of a REMS Document Guidance for Industry Clinical - Antimicrobial 10/11/2017 Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry