Style Manual and Content Templates
Style Manual
The following updates were made to the Style Guide:
| Location | Description |
|---|---|
| 3.7.2 | Capitalized "Standard English" |
| Table 3-3 | Removed italics from "in vivo" |
| Table 3-8 | Fixed capitalization |
| Table 4-9 | Added numbers to the list |
Content Templates
The following updates have been made to the included content templates:
| Template Location | Action |
|---|---|
| Module 1 EU\182-nfg-rmp\nfg-format-rmp-generics.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part1.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS1.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS2.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS3.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS4.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS5.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS6.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS7.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part2-MS8.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part3.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part4.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part5.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part6.doc | New |
| Module 1 EU\182-nfg-rmp\nfg-rmp-part7.doc | New |
| Module 1 EU\182-nfg-rmp\WC500134743.doc | New |
| Module 2\26-nonclin-sum\263-pharmacol-tabulated-summary.doc | Updated |
| Module 2\26-nonclin-sum\265-pharmkin-tabulated-summary.doc | Updated |
| Module 2\26-nonclin-sum\267-toxicology-tabulated-summary.doc | Updated |
| DINA\DINA 01-General.doc | New |
| DINA\DINA 02-Introduction.doc | New |
| DINA\DINA 03-Substance.doc | New |
| DINA\DINA 04-Product.doc | New |
| DINA\DINA 05-Miscellaneous.doc | New |
| Module 1 US\1-3-1-5-acceptance-of-IND-transfer.doc | New |
| Module 1 US\1-6-EOP2-meeting-request.doc | New |
| Module 1 US\1-9-4-pediatric-study-plan.doc | New |
| Module 1 EU\182-riskmgtsystem.doc | Removed |
| Module 1 US\1-9-5-proposal-for-written-agreement.doc | Removed |
| Module 1 US\1-11-2-nonclinical-information-amendment.doc | Updated |
| Module 1 US\1-11-3-clinical-information-amendment.doc | Updated |
| Module 1 US\1-11-4-multiple-module-information-amendment.doc | New |
| Module 1 US\1-12-11-anda-basis-for-submission-statement.doc | Updated |
| Module 1 US\1-12-17-orphan-drug-designation.doc | New |
| Module 1 US\1-12-2-request-to-charge-for-clinical-trial.doc | Updated |
| Module 1 US\1-12-3-request-to-charge-for-expanded-access.doc | Updated |
| Module 1 US\1-12-6-exemption-from-informed-consent-for-emergency.doc | Renamed |
| Module 1 US\1-12-7-public-disclosure-statement-informed-consent-for-emergency.doc | Renamed |
| Module 1 US\1-12-8-correspondence-regaring-exception.doc | New |
| Module 1 US\1-13-12-status-of-postmarketing-study-commitments-and-requirements.doc | Renamed |
| Module 1 US\1-13-13-status-of-other-postparketing-studies-and-requirements.doc | Renamed |
| Module 1 US\1-13-15-development-safety-update-report.doc | New |
| Module 1 US\1-14-6-product-labeling-for-2253-submissions.doc | New |
| Module 1 US\1-15-promotional-material-TYPE.doc | Renamed |
| Module 1 US\1-16-risk-management-plan.doc | Updated |
| Module 1 US\1-17-1-correspondence-regarding-postmarketing-commitments.doc | New |
| Module 1 US\1-17-2-correspondence-regarding-postmarketing-requirements.doc | New |
| Module 1 US\1-18-proprietary-names.doc | New |
| Module 1 US\1-19-pre-eua-and-eua.doc | New |
| Module 1 US\1-20-general-investigational-plan-for-initial-ind.doc | New |
| Module 1 US\1-3-1-5-change-in-ownership-of-an-application-or-reissuance-of-license.doc | Renamed |
| Module 1 US\1-3-5-3-exclusivity-claim.doc | Updated |
| Module 1 US\1-3-6-tropical-disease-priority-review-voucher.doc | New |
| Module 1 US\1-4-4-cross-reference-to-previously-submitted-information.doc | Renamed |
| Module 1 US\1-5-1-withdrawal-of-an-IND.doc | Renamed |
| Module 1 US\1-5-5-withdrawal-of-an-unapproved-BLA-NDA-ANDA-or-supplement.doc | Renamed |
| Module 1 US\1-5-7-withdrawal-of-approval-of-an-application-or-revocation-of-license.doc | Updated |
| Module 1 US\1-7-4-correspondence-regarding-fast-track-rolling-review.doc | New |
| Module 1 US\1-8-4-animal-efficacy-study-for-approval-under-the-animal-rule.doc | New |
| Module 1 US\1-3-5-3-exclusivity-request.doc | Renamed |
| Module 1 US\1-5-7-request-for-withdrawal-of-application-approval.doc | Renamed |
| Module 1 US\1-11-2-safety-information-amendment.doc | Renamed |
| Module 1 US\1-11-3-efficacy-information-amendment.doc | Renamed |
| Module 1 US\1-12-2-request-to-charge.doc | Renamed |
| Module 1 US\1-12-3-notification-of-charging-under-treatment-ind.doc | Renamed |
| Module 1 US\1-12-11-basis-for-submission-statement.doc | Renamed |
| Module 1 AU\1-0-0-electronic-lodgement-cover-sheet.doc | New |
| Module 1 AU\1-0-1-letter-of-application.doc | New |
| Module 1 AU\1-0-2-responses-to-questions.doc | New |
| Module 1 AU\1-1-comprehensive-table-of-contents.doc | New |
| Module 1 AU\1-10-1-overseas-regulatory-status.doc | New |
| Module 1 AU\1-10-2-product-information-from-countries.doc | New |
| Module 1 AU\1-10-3-differences-in-the-data-set-in-applications-to-countries.doc | New |
| Module 1 AU\1-11-1-summary-of-bioavailability.doc | New |
| Module 1 AU\1-11-2-justification-for-not-providing-biopharma-studies.doc | New |
| Module 1 AU\1-12-paediatric-development-program.doc | New |
| Module 1 AU\1-13-risk-management-plan-for-australia.doc | New |
| Module 1 AU\1-2-1-application-form.doc | New |
| Module 1 AU\1-2-2-pre-submission-details.doc | New |
| Module 1 AU\1-2-3-patent-certification-documents.doc | New |
| Module 1 AU\1-3-1-product-information-and-package-insert.doc | New |
| Module 1 AU\1-3-2-consumer-medicines-information.doc | New |
| Module 1 AU\1-3-3-declaration-concerning-the-use-of-human-embryos.doc | New |
| Module 1 AU\1-3-4-labels.doc | New |
| Module 1 AU\1-4-1-information-about-the-expert-quality.doc | New |
| Module 1 AU\1-4-2-information-about-the-expert-nonclinical.doc | New |
| Module 1 AU\1-4-3-information-about-the-expert-clinical.doc | New |
| Module 1 AU\1-5-1-literature-based-submission-documents.doc | New |
| Module 1 AU\1-5-2-orphan-drug-copy-of-orphan-drug-designation.doc | New |
| Module 1 AU\1-5-3-gmo-consent-from-the-ogtr.doc | New |
| Module 1 AU\1-5-4-additional-trade-name-declarations.doc | New |
| Module 1 AU\1-5-5-comarketed-medicine-declarations.doc | New |
| Module 1 AU\1-6-1-relevant-drug-and-plasma-master-files.doc | New |
| Module 1 AU\1-6-2-applicants-declaration.doc | New |
| Module 1 AU\1-6-3-letter-of-access.doc | New |
| Module 1 AU\1-6-4-certificates-of-suitability.doc | New |
| Module 1 AU\1-7-1-australian-manufacturer.doc | New |
| Module 1 AU\1-7-2-overseas-manufacturer.doc | New |
| Module 1 AU\1-7-3-applications-for-tga-gmp-clearances.doc | New |
| Module 1 AU\1-8-1-details-of-compliance-with-pre-.doc | New |
| Module 1 AU\1-8-2-details-of-any-additional-data-to-be-submitted.doc | New |
| Module 1 AU\1-8-3-declaration-of-complicance-with-presubmission-planning form and letter.doc | New |
| Module 1 AU\1-9-individual-patient-data.doc | New |
| Module 1 AU\annex-i-antibiotic-resistance-data.doc | New |
| Module 1 AU\annex-ii-overseas-evaluation-reports.doc | New |
| Module 5\53-clin-stud-rep\536-development-safety-update-report.doc | New |