IND Submissions: A Primer provides a hands-on approach that teaches regulatory professionals novice and veteran alike to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book s writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples. IND Submissions: A Primer is the only comprehensive IND manual of its kind. This 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs. It is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional. Specific topics include: * Regulations and guidance document references. * Overview and background of why the submission is required. * Structure of the submission itself. * Details on who should contribute to the submission. * Where to pull, re-use, or start as a basis for information needed in a submission. * Tips and lessons learned from the author's experience. * Different perspectives on how a submission can be approached. * Applicable FDA Form 1571 information for each submission. * Paper publishing tips. * Electronic CTD publishing sections for each submission, where applicable. * Real life examples taken from the press and approved NDAs when available. * Electronic examples and content templates to utilize so that an RA professional can begin immediately working on a submission.

IND Submissions: A Primer

Medical Books

Meredith Brown-Tuttle

Medicine

Parexel Intl Corp

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, Institutions, or individuals to significant liability risks and call into question the potential integrity of clinical data. Today s US-based clinical trials must meet not just federal requirements, but an increasingly complex array of state specific requirements as well. In fact, many areas critical and foundational to clinical studies age of consent, capacity to consent, notification of state agencies, experimental drug dispensing requirements, genetic testing, and legal representatives, among many others are driven by state, and not federal, laws. How do you monitor the requirements of all 50 states? State-by-State Clinical Trial Requirements Reference Guide 2012 provides totally updated and expanded profiles of the clinical trial standards in all 50 states. This newly updated resource breaks down each state s requirements in more than a dozen practical areas critical to your clinical research programs, including: * State statutory structures for clinical trials * Required notifications to state officials/offices * Legal representative standards * Age of consent/Capacity to consent * Drug dispensing/administration requirements * Informed consent, IRB, and clinical protocol requirements * State licensing authorities (medical, nursing, pharmacy) * Special state rules for cancer research * State HIV testing rules * State requirements for genetic testing * State-specific benefits afforded clinical research

State-by-State Clinical Trial Requirements Reference Guide (Serio)

Science & Math

John C. Serio

Chemistry

Featuring An All-New Index of Topics! This industry-leading GCP training and reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. And, in response to popular demand, the 2013 edition features an all-new index, making topic research easier than ever before. The completely updated and expanded 2013 guide includes: * Input from an Expert Advisory Panel including distinguished international GCP experts who have assured that the book contains the most current and up-to-date information on global GCP requirements. * Over 100 new Q&amp;As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials, and new changes and information to be provided in informed consent documents. * Revisions and updates to the section on HIPAA and privacy on this tenth anniversary of the implementation of the law. * Updated information on electronic records and use of EMR in clinical research. * Completely updated sections featuring all the latest data and trends on the FDA and EMA s clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US. * Updates to information on Latin America, India, Russia, Ukraine, and China, and the addition of GCP information for Canada. Read how the FDA is focusing more intently on sponsors quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. In Barnett s comprehensive guide, you'll have authoritative answers to hundreds of common and emerging questions in 20+ GCP-related areas, right at your fingertips: * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections, Investigational Drug Accountability, Administration, and Labeling

Good Clinical Practice: A Question & Answer Reference Guide, May 2013

Michael Hamrell

Reference

Medical Device Development: Regulation and Law, 2014 Edition, is the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. Since the 2009 edition of this book, new device legislation has been enacted and FDA has issued over a dozen or more important new guidances. The 2014 edition features in-depth analysis of these developments, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the US. The 2014 edition of this popular and authoritative resource reviews and analyzes the following critical developments since the 2009 edition: * Update on all the new provisions of the Food and Drug Administration Safety and Improvement Act of 2012 (FDASIA). * New statutory provisions and guidances related to device reclassification, humanitarian devices, the CDRH appeal process, Section 522 postmarket surveillance, and custom devices. * New statutory provisions and guidances related to mobile medical apps and medical device software, including medical data software systems. * Updates on the new organizational structure of CDRH, including revisions to the structure of the Office of Device Evaluation the Office of Compliance, and the Office of In Vitro Diagnostics and Radiological Health. * Changes to the 510(k) premarket notification process, including new policies on split predicates, when a device cannot be found to be SE, and the new priority review guidance. * Changes to the pre-submission process, including the end of the pre-IDE process and the birth of the Q-sub. * New guidances on FDA s Refusal to Accept policies relating to 510(k)s, PMA s, and pre-submissions. * Update on the investigational device exemption process, including new guidances on early feasibility studies, FDA decisions for IDE investigations, design considerations for pivotal clinical device investigations, and good laboratory practices. * Changes to the premarket approval application process, including birth of the e-copy and modifications to the advisory panel process. * New policies and guidances concerning in vitro diagnostic products, including the new guidances on Research Use Only (RUO)/Investigational Use Only (IUO) products, and in vitro companion diagnostics. * Update on device compliance issues, including the 2013 draft medical device reporting guidance and recall procedures relating to product enhancements. * New guidances and cases relating to combination products incorporating medical devices.

Medical Device Development: Regulation and Law

Jonathan S. Kahan

Hogan Lovells US LLP

This industry-leading GCP reference guide answers over 1,200 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2014 guide includes: In-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements. * Over 100 new Q&amp;As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials and updated information on the role and responsibilities of IRBs. * Revisions and updates to the section on HIPAA and privacy. * Updated information on electronic records and use of EMRs in clinical research. * Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Many Q&amp;As added regarding clinical trials and GCP for medical devices. * Updates to information on Latin America, India, Russia, Ukraine, Canada, and China, and the addition of GCP compliance and clinical trial requirements for Australia, New Zealand, and Israel. * Insights into how the FDA is focusing more intently on sponsors quality systems and risk-based approaches, especially when significant problems are discovered at the clinical study site, why significant non-compliance is still being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. * *Read how the FDA is focusing more intently on sponsors quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. In Barnett's comprehensive guide, you'll have authoritative answers to hundreds of common and emerging questions in 20+ GCP-related areas, right at your fingertips: * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections, Investigational Drug Accountability, Administration, and Labeling

Good Clinical Practice: A Question & Answer Reference Guide, May 2014

Barnett International's industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2015 guide includes: In-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements. * Over 100 new Q&amp;As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials and updated information on the role and responsibilities of IRBs. * Revisions and updates to the section on HIPAA and privacy. * Updated information on electronic records and use of EMRs in clinical research. * Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * 200+ Q&amp;As updated to reflect the very latest FDA guidances, regulations, comments, and developments. * Many Q&amp;As added regarding clinical trials and GCP for medical devices. * Updates to information on Latin America, India, Russia, Canada, and China, as well as GCP compliance and clinical trial requirements for Australia, New Zealand, and Israel. * Insights into how the FDA is focusing more intently on sponsors quality systems and risk-based approaches, especially when significant problems are discovered at the clinical study site, why significant non-compliance is still being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. * *Read how the FDA is focusing more intently on sponsors quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. In Barnett's comprehensive guide, you'll have authoritative answers to hundreds of common and emerging questions in 20+ GCP-related areas, right at your fingertips: * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections, Investigational Drug Accountability, Administration, and Labeling

Good Clinical Practice: A Question & Answer Reference Guide, May 2015

Barnett International

This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2016 guide includes: Over 15 new contributing domestic authors with targeted expertise in QA, Monitoring, Compliance, Site Management and several other core GCP areas. * Dozens of new Q&amp;As, including in-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements. * New questions and answers related to GCP expectations, including risk-based monitoring, electronic informed consent and records, social media, HIPAA, and the role and responsibilities of IRBs. * Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * Updates to reflect the very latest FDA guidances, regulations, comments, and developments for both drugs and devices. * Updates to information on Australia, Canada, China, India, Israel, Latin America, New Zealand, and Russia. * Insights into FDA's focus on sponsors quality systems and risk-based approaches, especially when GCP compliance issues are discovered at the clinical study site.

Good Clinical Practice: A Question & Answer Reference Guide, May 2016

Earl W. Hulihan

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2016/2017 is the leading resource for statistics, trends, and proprietary market intelligence and analyses on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development from product discovery, to R&D performance and productivity, to time-to-market trends. With real-world analysis and key contributions from leading consultancies and experts, the Sourcebook includes: * New proprietary analysis on US clinical trial starts, segmented by therapeutic category, as well as overall active clinical trials * Emerging data on worldwide and company-specific R&D pipelines and product launch trends * New analysis on emerging trends in pharma and biotech licensing deals and other partnerships critical to industry's R&D pipeline* Drug approval statistics compiled from FDA, EMA, and other regulatory agencies * New global R&D spending trends and other international R&D data from key markets * International statistics on drug development output... And much more! Spotlight analyses on emerging and re-emerging elements of industry's R&D pipeline, including immuno-oncology, antibiotics, and gene therapy * Assessments of several emerging industry controversies, including drug pricing, the wisdom of ultra-rapid new drug reviews, and R&D overcrowding in some parts of the new drug pipeline * Analyses on the state, nature, and sustainability of industry's pipeline of R&D projects * Detailed profiles on the pipelines and emerging R&D models and structures used by leading pharma companies * Analyses focused on the drug and biopharma markets and development pipelines within emerging countries, including South Korea and China * Assessments of personalized medicine/companion diagnostics, biosimilars, orphan drugs, and other factors reshaping biopharma R&D today. PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2016/2017 is a must-have resource for the drug development industry. It is invaluable to executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.

PAREXEL Biopharmaceutical R&D Statistical Sourcebook 2016/2017

Mark P. Mathieu

This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2017 guide includes: * Updates focused specifically on the revision of ICH GCP (E6 R2) and the impact on clinical trial processes and systems. * Over 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, TMF, Data Management and many other core GCP areas. * Dozens of new Q&amp;As, including in-depth analysis from distinguished international GCP expectations, including risk-based monitoring, electronic informed consents, eSource, TMF readiness and others. * Newly-added chapters on clinical data management and the TMF. * Completely updated sections featuring all the latest data and trends on the FDA and EMA s clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * Updates to reflect the very latest FDA guidances, regulations, comments, and developments for both drugs and devices. * Updates to information on Australia, Canada, China, India, Israel, Latin America, New Zealand, and Russia. * Insights into FDA s focus on sponsors quality systems and risk-based approaches, especially when GCP compliance issues are discovered at the clinical study site.

Good Clinical Practice: A Question & Answer Reference Guide, May 2017

This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2018 guide includes: * Continued updates focused on the impact of changes to ICH GCP E6 R2, enforcement of the revisions and its impact on clinical trial processes and systems, including Quality-by-Design and Risk-based Quality Management (QM) expectations. * Dozens of new Q&amp;As including FDA s guidance on R2 implementation, status of the EU Directive update, and changes to US FDA Compliance Program Guidance Manual 7348.10. * Updates on the EU s new General Data Protection Regulation (GDPR) and the MHRA 2018 Data Integrity Guidance. * Coverage on updates to the Common Rule and NIH updates for clinical trials research. * New questions focused specifically on how Risk-based Quality Management (Section 5 of the Addendum) impacts monitoring activities. * Updates to state- and country-specific regulations including the US, Brazil, Argentina, Peru, India and many others. * Over 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, the Trial Master File, Data Management and many other core clinical research areas. * Plus extensive graphs and charts on latest inspection trends and findings!

Good Clinical Practice: A Question & Answer Reference Guide, May 2018

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