FDA review

Errors and Inconsistencies in Formatting Dates. It is also necessary to use standardized formats to record dates. For example, Oracle stores a date as the number of seconds since January 1, 4712 BC, and then uses various functions to display the dates in more human-friendly formats. There are many different and personal ways for recording dates one of the authors (AS) has noted at least 25 different ways in a single clinical trial submitted for FDA review Should February 1,2007 be recorded as 1 February 2007,1 Feb 2007, 1 Feb 07, or 02/01/07 This problem still exists when data for numerical dates are extracted into software programs such as Excel that do not force the user to select a unique format for dates. 

The NADA method approval process consists of three phases (1) method development by the sponsor and generation of information to establish that the method satisfies acceptability criteria (2) FDA review of the sponsor s data to determine suitability of the method and (3) the method trial , an inter-laboratory study, which determine whether the method meets performance criteria when used in multiple laboratories. The inter-laboratory method trial procedure provides an indication of a method s ability to be used as a practicable and reliable regulatory tool. Sponsors are urged to develop methods that are mgged and exceed rather than meet the minimal standards of acceptability. Those methods that appear marginally acceptable after review often do not pass the inter-laboratory method trial. 

Cannabinoid receptor CB,-blockers, such as rimonabant (under FDA review)... 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

Natural and herbal diet pills available in the United States today are considered dietary supplements and are not subject to FDA review prior to being sold. Although these agents may have drug-like activity in the body, they do not need to be proven safe or effective like conventional drugs do. Unlike conventional drugs, natural and herbal diet pills can only be withdrawn from the market when they are proven to be dangerous. As a result, many herbal products reach the market without any scientific evidence that they are safe or effective. These products are discussed in more detail in Chapter 6. 

Information on existing or new excipients can be described and provided to the FDA in an NDA directly. Alternatively, the manufacturers of excipients may prepare and submit type IV Drug Master Files (DMF) to support the use of an excipient in one or more NDAs. The DMFs are discussed in FDA s regulations under 21 CFR Section 314.420 and the FDA-issued Guidance for Drug Master Files (8). When authorized by the DMF submitter (i.e., the excipient manufacturer) and cross-referenced by an NDA submitter, the FDA reviews the DMF to make determinations on the safety, manufacture, and quality of the excipient use in the new drug that is the subject of the then pending NDA. The DMF becomes active when reviewed in conjunction with the review and approval of an NDA. 

The Type V DMF enables confidential information to be submitted to the FDA, for example, a contract manufacturing facility may provide proprietary information to the FDA without divulging it to the Sponsor client. The FDA reviews the DMF, but the DMF is never approved or disapproved. The holder of the DMF is notified of deficiencies for rectification. It is the holder s responsibility to update the DMF on an annual basis. 

To What Extent Does 30 Months Approximate the Time Typically Required for FDA Review of a Generic s AND A or for Resolution of the Contemplated Patent Infringement Litigation ... 

There have been various suggestions to address this situation, each with its own pros and cons. One proposal has been to establish an administrative procedure through which generic applicants could obtain substantive FDA review of listability. The FDA, however, has taken the position that it lacks the expertise and resources necessary to perform such a review, and its solely ministerial review of Orange Book listings has been upheld by the courts. At a minimum, it appears useful for the FDA to clarify its listing requirements see Appendix H). 

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