PDF-Draft Guidance Temp05/22/15

Established Conditions Reportable CMC Changes for Approved Drug and Biologic ProductsGuidance for IndustryDRAFT GUIDANCEThis guidance document is being distributed for comment purposes onlyComments. 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be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit written comments to the Di vision of Dockets Mana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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic com ments to httpwwwregulationsgov Su Comments and suggestions regarding this draft document should be subm itted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http It does not create or confer any rights for or on any person and does not operate to bind FDA or the public You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations If you want to disc 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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management HF Com ents and suggestio ns regar ing this draft do cu ent should be sub itted wit in 9 0 days of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 Contains Nonbinding Recommendations Draft – Not for Implementation What Is the Relationship Between Potency and Clinical Effectiveness for CGT RECOMMENDATIONS FOR POTENCY MEASUREMENTSHow to Det This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does no