{"product_id":"book-14-2026-selected-recently-finalized-fda-guidance-documents","title":"Book 14:  2026 Selected Recently-Finalized FDA Guidance Documents","description":"\u003cdiv id=\"tabs\"\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#tabs-1\"\u003eDescription\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-2\"\u003eContents\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-3\"\u003eCover\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv id=\"tabs-1\"\u003e\n\u003cp class=\"bigblacktext\" align=\"left\"\u003e\u003cspan class=\"smallgray\"\u003eRapidly becoming one of our most popular titles, this spiral-bound, 5\" x 7.5\" book is a collection of FDA Guidance documents.  It includes those guidances that are most applicable to clinical research staff and includes such topics as:\u003cbr\u003e\u003cbr\u003e• Maximum safe starting dose estimates\u003cbr\u003e• Safety assessments prior to drug marketing\u003cbr\u003e• Collecting race\/ethnicity data in trials\u003cbr\u003e• Nonclinical evaluation of potential for delayed QT\u003cbr\u003e   interval prolongation by human pharmaceuticals\u003cbr\u003e\u003cbr\u003eThis book is ideal for clinical research staff involved in developing and reviewing protocols, performing safety assessments, and\/or writing clinical study reports. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003eWhat's the Price?\u003c\/span\u003e\u003cbr\u003e\u003cspan class=\"smallgray\"\u003e• 1-249 copies:  $18.95             • 250-499 copies:  $17.95\u003cbr\u003e• 500-749 copies: $16.95          • 750+ copies:  $15.95\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003eCustom Cover Prices*?\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e\u003cbr\u003e• 1-24 copies:  unavailable             • 25-100 copies:  $2.00\/book\u003cbr\u003e• 100-249 copies: $1.00\/book        • 250+ copies:  No charge \u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e\u003c\/span\u003e\u003cbr\u003e\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e* Based on quantities of a single book title\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-2\"\u003e\n\u003cp class=\"smallgray\" align=\"left\"\u003e\u003cspan style=\"color: #000000;\" color=\"#CC0000\"\u003e• EU Regulation No. 536\/2014 on Clinical Trials on Medicinal\u003cbr\u003e  Products for Human Use, and Repealing Directive 2001\/20\/EC\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e\u003cspan style=\"color: #000000;\" color=\"#CC0000\"\u003e• Draft FDA Guidance: Electronic Source Data in Clinical Investigations\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e• FDA Policy for Conducting a Clinical Safety Review of an\u003cbr\u003e  NDA or BLA (FDA Manual of Policies and Procedures,\u003cbr\u003e  MAPP #6010.3, Rev. 1)\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e• Exception from Informed Consent Requirements for\u003cbr\u003e   Emergency Research\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e•\u003cspan style=\"color: #cc0033;\" color=\"#CC0033\"\u003e \u003c\/span\u003e \u003cspan style=\"color: #000000;\" color=\"#000000\"\u003eAdverse Event Reporting to IRBs - Improving Human\u003cbr\u003e  Subject Protection\u003cbr\u003e\u003cbr\u003e• Exploratory IND Studies\u003cbr\u003e\u003cbr\u003e• Estimating the Maximum Safe Starting Dose in Initial\u003cbr\u003e  Clinical Trials for Therapeutics in Adult Healthy Volunteers\u003cbr\u003e\u003cbr\u003e• Collection of Race and Ethnicity Data in Clinical Trials\u003cbr\u003e\u003cem\u003e\u003cbr\u003e\u003c\/em\u003e• Nonclinical Evaluation of the Potential for Delayed\u003cbr\u003e  Ventricular Repolarization (QT Interval Prolongation) by\u003cbr\u003e  Human Pharmaceuticals (ICH S7B)\u003cbr\u003e\u003cbr\u003e• Premarketing Risk Assessment\u003cbr\u003e\u003cbr\u003e• Recommended Approaches to Integration of Genetic\u003cbr\u003e  Toxicology Study Results\u003cbr\u003e\u003cbr\u003e• Fast Track Drug Development Programs - Designation, \u003cbr\u003e  Development, and Application Review\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-3\"\u003e\n\u003cp\u003eClick \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/book14coiled.pdf?v=1744818250\"\u003ehere\u003c\/a\u003e to see an enlarged pdf cover\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Clinical Research Resources, LLC","offers":[{"title":"Default Title","offer_id":44561131044979,"sku":null,"price":18.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/2026book14coiled.png?v=1775165372","url":"https:\/\/www.clinicalresearchresources.com\/products\/book-14-2026-selected-recently-finalized-fda-guidance-documents","provider":"Clinical Research Resources, LLC","version":"1.0","type":"link"}