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(b) (4) - accessdata fda 2025

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The document is a microbiology review for the New Drug Application (NDA) 22-442 for the drug product REZIRA, which contains Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride. The review, dated March 16, 2009, concludes with a recommendation to approve the application from a quality microbiology standpoint, noting that it is a non-sterile oral pharmaceutical product with no microbiology deficiencies identified.

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What is the FDA approval of 505b2?

The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (reference or listed) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.

Are FDA 483s public information?

Lets first be clear that while FDA publishes a subset of the FDA 483 public record on its website, not all 483s are published there for easy access. If you want to see any unpublished 483, you have to make a special request, which takes time and money.

What does it mean to get a 483 from the FDA?

The FDA Form 483 is officially called a Notice of Inspectional Observations, commonly referred to simply as a 483. The 483 is issued at the end of an on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act.

What does b )( 4 mean in FDA?

Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by (b)(4). If a report contains personal or medical files information, that text is replaced by (b)(6).

What is Phase 4 FDA approval?

Phase IV studies look at drugs that have already been approved by the FDA. The drugs are available for doctors to prescribe for patients, but phase IV studies might still be needed to answer important questions. These studies may involve thousands of people.

What are the three most frequent 483 findings?

We have taken care to consider this when selecting our top 10 most common types of observation, which are: Failure to properly handle, store, or label materials. Failure to establish or maintain adequate records or logs. Failure to properly report adverse events or incidents.

What is a 483 classification?

A 483 is the document that the FDA issues at the close of an inspection where they identify observations made during the inspection. If no observations are made, no 483 is issued. Based on the response submitted by the firm, the FDA classifies the inspection as: No Action Indicated (NAI) when no 483 is issued.

What is FDA 483 database?

A Form FDA 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic (FDC) Act and other Acts or regulations.

(b) (4) - accessdata fda 2025

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