PDF-Guidance for Industry Applications for Premarket Review of New Tobacco Products DRAFT

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be sub itted wit in 9 0 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Subm it comments to the D ivision of Dockets Manage e. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana 574115745557453574535744557454574605745957376574415745457444573765745957461574475744757445574595746057449574555745457459573765745857445574475744157458574445744957454574475737657460574485744957459573765744457458574415744657460573765744457455574435746 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration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 Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER January 2010 Clinical Medical brPage 2br Guidance for Industry Assessment of Abuse Potential of Dr . Les Weinstein. FDA’s Center for Tobacco Products (CTP): Overview of Requirements & Advice on How to Navigate Through Them. WT North America Conference. Richmond, Virginia. May 12-14, 2015. 2. Advertisements for tobacco products often feature healthy, attractive people sending the message that using tobacco has no health consequences.. ALL tobacco products contain warning labels that inform the user that tobacco products can be harmful to an individuals health.. 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