PPT-Draft Guidance for Industry: Information Requests and Discipline Review Letters Under

Overview of Presentation Background Discipline Review Letter DRL Information Request IR IRDRL Timing IRDRL Responses Key Takeaways Resources wwwfdagov Background The Generic Drug User Fee Amendments of 2017 GDUFA II was signed into law on August 18 2017 in order to facilitate timely access to high quality affordable generic medicines. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana 5741157455574535745357445574545746057459573765744157454574445737657459574615744757447574455745957460574495745557454574595737657458574455744757441574585744457449574545744757376574605744857449574595737657444574585744157446574605737657444 Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Subm it comments to the D ivision of Dockets Manage e Comments and suggestions regarding this draft docu ment should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H 4 9 DRAFT GUIDANCE ) or the Office of Communication, Outreach, and Development (CBER) at 8004709 or 240 27 U.S. Department of Health and Human ServicesFood and Drug Administration Center for Device Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders DRAFT GUIDANCE Communication, Outreach, and Development (CBER) at 800-835-4709 or 240-402-7800. U.S. Departme Representative: First Last. Date: . February . 4. , 2015. Location: . Misc. . Conference Room. Management Review Agenda. Roll Call of Attendees (5.6.1). Suitability of Quality Policy (5.3e). Status of Quality Objectives (.