PDF-Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE

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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub.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be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S 5741157455574535745357445574545746057459573765744157454574445737657459574615744757447574455745957460574495745557454574595737657458574455744757441574585744457449574545744757376574605744857449574595737657444574585744157446574605737657444 Comments and suggestions regarding this draft document should be subm itted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H 574115745557453574535744557454574605745957376574415745457444573765745957461574475744757445574595746057449574555745457459573765745857445574475744157458574445744957454574475737657460574485744957459573765744457458574415744657460573765744457455574435746 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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER March 2014 ClinicalMedical 16617dftdoc 030614 brPage 2br Guidance for Industry Chronic Fatigue Sy Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Submit written Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of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 Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale B . All comments should be identified with the docket number listed in the notice of availability that publishes in theFor questions regarding this draft document,Center for Drug Evaluation and Researc Overview of Presentation. Background. Discipline Review Letter (DRL). Information Request (IR). IR/DRL Timing . IR/DRL Responses. Key Takeaways. Resources. www.fda.gov. 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.. 15028dft.doc 07/27/16 Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampsh G:\5412dft.doc01/02/03 G:\5412dft.doc01/02/03 The Division of Drug Information (HFD-240)Center for Drug Evaluation and Research (Tel) 301-827-4573 Draft — Not for ImplementationG:\5412dft.doc01/0