FDA guidance

An abbreviated 510(k) is based on making a declaration of conformity to a recognised standard, special control, or specific FDA guidance. Again, the manufacturer must provide test data in support of this assertion. 

FDA Guidance Guideline on general principles of process validation. www.fda.gov. 

FDA Guidance Guidance for Industry Part 11, Electronic Records Electronic... 

FDA. Guidance for Industry. PAT—A Framework for Innovative Pharmaceutical Development, Mannfactnring, and Qnality Assurance, http //www.fda.gov/cder/ guidence/6419fnl.htm... 

CFR - Part 11 means that you must be qualified to do your work, your programming must be validated, you must have system security in place, and you must have change control procedures for your SAS programming. The current additional FDA guidance on 21 CFR - Part 11 is titled Guidance for Industry Part 11, Electronic Records Electronic Signatures—Scope and Application. ... 

Once your analyses and reporting are complete, you will probably need to export your SAS data to someone else. For clinical trials that are part of an FDA submission, the data export requirements are defined in the code of federal regulations and in FDA guidance. For clinical trials intended for other institutions, the data export requirements may vary widely. In this chapter we look at the various data export requirements and how you can use SAS to create data files for export. 

Under this proposal, a manufacturer would use the FDA guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device, and... 

FDA Guidance for Industry Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/ Active Ingredients Based on a Biopharmaceutics Classification System, CDER-GUID 2062dft.wpd Draft, Jan. 1999. 

Recent US FDA guidance on safety testing of drug metabolites [5] highlights the importance of measuring major metabolites in human and toxicological species. This increased scrutiny on the role of metabolites in the evaluation of efficacy and safety will lead to increasing demand for metabolites as analytical standards. 

FDA, Guidance for Industry. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. For further informatio, visit http // www.fda.gov/cder/guidance/ index.htm. 

FDA, Guidance for Industry Drugs, Biologies, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Draft Guidance). United States Food and Drug Administration,... 

FDA Guidance for Industry, Part 11, Electronic Records Electronic Signatures - Scope and Application (Final version, August 2003), Center for Dmg Evaluation and Research (CDER), US Food and Drug Administration (FDA), Beltsville, MD, USA, 2003. 

According to the FDA guidances, if the drug is sufficiently highly soluble and permeable, and dissolution of the drug from the reference and test products occurs to an extent of 85% of label strength or better within 30 min in three media (pH 1.2, 4.5, and 6.8 are currently recommended), this is viewed as adequate proof of bioequivalence, provided the... 

FDA. Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Revised) (I). Rockville MD, USA U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2003. 

This chapter focuses primarily on the development and evaluation of IVIVC for ER oral products in accordance with the 1997 FDA Guidance. However, as the CPMP guidance provides almost identical information on these topics, the dis-... 

The FDA guidance on IVIVC development and validation states that crossover studies are preferred however, parallel studies or cross-study analyses may be acceptable. The advantage of a crossover study is that it avoids bias to any one particular treatment as a result of a period effect. A crossover study also provides the highest probability of successfully validating the IVIVC, since it avoids the variability introduced by cross-study comparisons. 

The FDA guidance on IVIVC development and validation defines a number of circumstances where an IVIVC can be used to justify a biowaiver request in support of (1) level 3 process changes, (2) complete removal or replacement of non-release-controlling excipients, (3) level 3 changes in release-controlling excipients, (4) approval of lower strengths, and (5) approval of new strengths. Additionally, use of the IVIVC to justify biorelevant dissolution specifications is cited as the optimal approach. 

FDA. Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Rockville Center for Drug Evaluation and Research, 1997. 

FDA Guidance. Dissolution Testing of IR Solid Oral Dosage Forms (Appendix A), Apparatus August 1997. 

FDA Guidance. Submitting Samples and Analytical Data for Methods Validation Appendix C, B. Automated Methods. February 1987. 

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