Since mid-2008 FDA is redesigning their website. Starting with June 2009 most links to guidances are broken without automatic redirect to new URIs (even FDA’s search-page sometimes leads to a nonexisting resource)…
Documents by title, date, old, and new resources. Click on the heading to sort (JavaScript required):
title | date | old URL | new URL |
---|---|---|---|
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation SUPAC-IR Questions and Answers about SUPAC-IR Guidance |
1995/11 | ? |
ucm070636.pdf ucm124826.htm |
SUPAC-MR: Modified Release Solid Oral Dosage Forms | 1997/09 | UCM070640.pdf | |
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations | 1997/09 | ucm070239.pdf | |
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products | 1998/05 | UCM072008.pdf | |
Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation |
1997/05 | ucm070930.pdf | |
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling | 1998/05 | ucm072127.pdf | |
Population Pharmacokinetics | 1999/02 | ucm072137.pdf | |
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products | 1998/11 | ucm072114.pdf | |
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act | 1998/06 | ucm079342.pdf | |
In Vivo Drug Metabolism/Drug Interaction Studies — Study Design, Data Analysis, and Recommendations for Dosing and Labeling | 1999/11 | ucm072119.pdf | |
Changes to an Approved NDA or ANDA | 2004/04 | ucm077097.pdf | |
Statistical Approaches to Establishing Bioequivalence | 2001/01 | ucm070244.pdf | |
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System | 2000/08 | ucm070246.pdf | |
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling | 2003/05 | ucm072123.pdf | |
Bioanalytical Method Validation | 2001/05 | ucm070107.pdf | |
Food-Effect Bioavailability and Fed Bioequivalence Studies | 2002/12 | ucm070241.pdf | |
Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications | 2003/04 | ucm072109.pdf | |
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations | 2003/03 | ucm070124.pdf | |
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action Statistical Information for In Vitro Bioequivalence Data |
2003/04 | ucm070111.pdf ucm070118.pdf |
|
Handling and Retention of BA and BE Testing Samples | 2004/05 | ucm072869.pdf | |
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers | 2005/07 | UCM078932.pdf | |
Part 11, Electronic Records; Electronic Signatures — Scope and Application | 2003/03 | UCM072322.pdf | |
Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling | 2006/09 | ucm072101.pdf | |
Bioequivalence Recommendations for Specific Products | 2007/05 | ucm072872.pdf | |
Computerized Systems Used in Clinical Investigations | 2007/05 | UCM070266.pdf | |
Submission of Summary Bioequivalence Data for ANDAs | 2009/04 | UCM134846.pdf | |
Formatting of Bioequivalence Summary Tables | 2007/01 | UCM120957.pdf ucm120960.doc |
|
Critical Path Opportunities for Generic Drugs | 2007/05 | ucm077250.htm | |
General Principles of Software Validation; Final Guidance for Industry and FDA Staff | 2002/01 | ucm085371.pdf | |
Review of Bioequivalence Studies with Clinical Endpoints in ANDAs | 2006/12 | ucm079585.pdf | |
Procedures for Review of Bioequivalence Study Protocols | 2006/07 | ucm079770.pdf | |
Inspections of Clinical Facilities and Analytical Laboratories Conducting Bioequivalence Studies Submitted in ANDAs | 2000/12 | ucm079772.pdf | |
Guideline for the Monitoring of Clinical Investigations | 1998/11 | ucm135075.htm | |
Institutional Review Boards | 1997/09 | UCM133768.pdf | |
Computerized Systems Used In Clinical Trials | 1999/04 | UCM133749.pdf ucm135196.htm |
|
Sponsors, Contract Research Organizations and Monitors | 2001/02 | UCM133770.pdf ucm133777.htm |
|
Clinical Investigators | 2008/12 | UCM133773.pdf ucm133562.htm |
|
GLP Final Rule (1978) | 1978/12 | UCM133728.pdf | |
GLP Proposed Rule (1984) | 1984/10 | UCM133729.pdf ucm072691.htm |
|
GLP Final Rule (1987) | 1987/09 | UCM133730.pdf ucm072706.htm |
|
GLP Questions and Answers (1981, 1999, 2007) | 2007/07 | UCM133748.pdf ucm072738.htm |
|
Reviewer Guidance – Validation of Chromatographic Methods | 1994/11 | UCM134409.pdf | |
CGMP for Phase 1 Investigational Drugs | 2008/07 | ucm070273.pdf |
document date 2009-06-12 | last update 2022-10-19