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Questions and Answers from the November 19, 2009 FDA - fda

Questions and Answers from the November 19, 2009 FDA - fda-2025

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The document is a compilation of questions and answers from the FDA-NCBFAA webinar held on November 19, 2009, focusing on the PREDICT system and various FDA import processes. It covers topics such as the rollout of the MARCS Imports Entry Review software, the functionality of the PREDICT risk evaluation tool, ITACS for communication between FDA and importers, Affirmation of Compliance codes, product code issues, firm identification challenges, data quality requirements, and the import alert process. The responses provide insights into operational timelines, compliance expectations, and improvements in import procedures.

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How many batches are required for process validation?

While it is recognised that the term validation is intended to apply to the final verification at the production scale (typically 3 production batches), the guidance presented here is intended to encompass the information that should routinely be included in the marketing authorisation application.

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10 Facts about What FDA Does and Does Not Approve Fact #1: Generic medicines work the same as brand-name medicines. Fact #2: Vitamins, minerals, herbs, and other dietary supplements are NOT FDA-approved to treat or prevent disease. Fact #3: The FDA doesnt approve compounded drugs.

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The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nations first consumer protection agency, the Food and Drug Administration (FDA).

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FDA 820.3 (b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Questions and Answers from the November 19, 2009 FDA - fda-2025

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