The 2019 CFR/ICH Reference Guide provides the critical information you need to know to stay current with the pharmaceutical industry’s codes and regulations.
The compact nature of the guide offers an easy way to keep key regulations right at your fingertips and readily available for quick reference. Updated as of April 1, 2019, regulations included are:
- FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56, 312 & 314
- ICH Guidelines Good Clinical Practice (E6 R2) and Clinical Safety Data Management (E2A)
The convenient and easy-to-reference pocket guide is ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, CROs, sponsors, investigator meetings, research facilities, hospitals conducting clinical research and more!
Updates this year include the fully revised International Conference on Harmonization E6 R2 guideline, which has significant implications for industry. Key changes include:
- The required implementation of a risk-based quality management plan approach (i.e. risk management/risk-based quality management)
- More efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results
- Other requirements that demand that new knowledge, skills and abilities are acquired and implemented
Ensure that you and your teams are aware of these changes!
Extensive updates to the CFRs, specifically to Part 314 – Applications for FDA Approval to Market a New Drug, including:
- New and updated definitions
- Procedures for submission of 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
- Supplements and changes to approved NDAs, waivers, and petitions to request changes from a listed drug
- ANDAs: content and format, supplements and other changes to approved ANDAs, and amendments to unapproved ANDAs
- Filing, receiving, approval, and refusal of approval of NDA and ANDAs
- Details for submitting patent information
- Content, format, and clarifications regarding notice of certification of invalidity, unenforceability, or noninfringement of a patent
- New drug product exclusivity