Guidance for Industry

Draft Guidance for Industry on Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients Availability Notice, Fed Regist. Docket No. 98-0193, 1998. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

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

Draft Guidance for Industry and FDA Staff Saline, Silicone Gel and Alternative Breast Implants. Washington DC, January 13, 2004. 

Investigating Out of Specification (005) Test Results for Pharmaceutical Production, FDA Draft Guidance for Industry (J IGUIDANC 121DFT.WPD) dated 9/4/98. 

FDA. Withdrawal of draft guidance for industry on Electronic Records Electronic Signatures, Electronic Copies of Electronic Records, Fed Regr 68 (23), 5645 (4 February 2003). 

FDA. Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997). 

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

FDA. Food and Drug Administration. Guidance for Industry, Pharmacoge-nomic Data Submissions. March 2005. 

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologies Evaluation and Research (CBER). Guidance for Industry Population Pharmacokinetics. http //www.fda.gov/cder/guidance/1852fnl.pdf (accessed October 1,... 

Guidance for Industry No. 118 Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues DRAFT GUIDANCE June6,2001, US Department of Health and Human Services, Public Health Service, Pood and Drug Administration, Center for Veterinary Medicine, RockvUle, MD (2001). 

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. ... 

In the FDA s Guidance for Industry E6 Good Clinical Practice Consolidated Guidance, an adverse event is defined as follows ... 

General Principles of Software Validation Final Guidance for Industry and FDA Staff, found at http //www.fda.gov/cdrh/comp/guidance/938.pdf. 

Before undertaking a discussion of the mathematics involved in the determination of reaction rates is undertaken, it is necessary to point out the importance of proper data acquisition in stability testing. Applications of rate equations and predictions are meaningful only if the data utilized in such processes are collected using valid statistical and analytical procedures. It is beyond the scope of this chapter to discuss the proper statistical treatments and analytical techniques that should be used in a stability study. Some perspectives in these areas can be obtained by reading the comprehensive review by Meites [84], the paper by P. Wessels et al. [85], and the section on statistical considerations in the stability guidelines published by FDA in 1987 [86] and in the more recent Guidance for Industry published in June 1998 [87],... 

Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. Center for Devices and Radiologic Health, FDA, Rockville, MD, 1997. 

Draft Guidance for Industry—Nasal Spray and Inhalation Solution, Suspension and Spray Drug... 

Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation, Nov. 13, 1998. 

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. 

US Food Drug Adminstration (2008) Guidance for Industry, Safety Testing of Drug Metabolites, http //www.fda. gov/cder/guidance/index.htm (last access October 2008). 

Guidance for industry, waiver for in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification system. August 2000, CDER/FDA. 

CDER Guidance for Industry. 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 US Food and Drug Administration, 1995. 

United States Department of Health and Human Services, Food and Dmg Administration, Guidance for Industry. Dmgs, biologies, and medical devices derived from bioengineered plants for use in humans and animals. 2002. 

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. 

U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for industry. Immunotoxicology evaluation of investigational new drugs, 2002. 

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