Approved NDA

The conditions whereby dandmff, seborrheic dermatitis, and psoriasis dmg products are generally recognized as safe and effective and are not misbranded is available (70). Specific active iagredients that can be used as well as the statement of identity, iadications for use, and required warnings, are identified. Products that do not meet all of these requirements are considered new dmgs and must have an approved NDA for the nonmonograph conditions. 

Class III recalls are those that involve violations of the law, but for which a health hazard is remote. Examples in this case include insect parts or droppings in flour, the marketing of a product without an approved NDA, unacceptable disintegration or dissolution of tablets, or swollen cans of certain food products [23],... 

Newborn jaundice, photochemical treatment of, 79 120 New chemicals, pricing of, 75 641-642 New Chemicals Program (EPA), 9 456 New Drug Application (NDA), 27 574 New drug approval (NDA) process, 78 698-701... 

An orphan drug is one that is intended for use in rare diseases and thus for which there is not a sufficient market to justify the investment needed to demonstrate safety and effectiveness in order to obtain approval of an NDA. Por more than 20 years PDA had permitted orphan drugs to be distributed through a permanent IND, with little or no thought that it would ever progress to an approved NDA. In 1983, Congress enacted the Orphan Drug Act to provide... 

The vast bulk of prescription drugs on the market today are subject to the requirement for some form of an approved NDA. Following enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, there are now three clearly established types of NDA a full NDA, a paper NDA [now called a Section 505(b)(2) NDA, after the provision in the FD C Act that created it], and an abbreviated NDA. Each of these is discussed in the sections that follow. 

The productivity of research and development efforts within the pharma industry has declined significantly in the past decade. While large numbers of INDs are submitted each year, only a small proportion in the pipeline emerges as NDA submissions or approvals. NDA submissions have fallen by half, from a high of 50 in 1995,... 

Therefore, to be marketed as a pharmaceutical, a botanical must traverse the modern regulatory process resulting in an approved NDA. The fact that no botanical is currently NDA-approved has caused many to speculate whether a botanical could ever make it through the rigorous U.S. drug development process, and still others to ask why one would choose to pursue this avenue, given the panoply of regulatory options already available to botanicals in the United States. 

A statement of each method used in the testing of the sample. The statement must indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method used is in the current revision of the U.S. Pharmacopeia (USP), National Formulary (NF), or other recognized standard reference or if it is detailed in an approved NDA, this statement will not be required.)... 

U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidance for industry Changes to an approved NDA or ANDA, available http //www.fda.gov/cder/guidance/3516fnl.pdf, accessed Apr. 15,2006. 

Figure 5. Duration in months of IND (mean time from IND filing to NDA submission), NDA (mean time from NDA submission to NDA approval), and Total (mean time from IND filing to NDA approval) stages for approved NDAs by year of NDA approval. Data from U.S. and foreign companies are combined and the figures at the bottom indicate the number of NDAs approved each year for U.S. and foreign companies (13).

CDER-approved products are considered those subject to an approved NDA or ANDA. Some information on which components/materials aie used in CDER-approved products is available from the Agency (e.g., FDA, CDER, Inactive Ingredient Guide, 1996, Division of Drug Information Resources). When infonnation is not available, an applicant should use reliable sources of infonnation to determine that the component or material has been used in and has been in contact with a CDER-approved product of the same dosage form and route of administration, as appropriate. The applicant should identify in the supplement or annual report the basis for the conclusion that the component or material is used in a CDER-approved product. 

Changes in nonsterile semisolid dosage forms should be reviewed against the November 1999 FDA guidance for industry Changes to an Approved NDA or ANDA and the SUPAC Guidance for Industry Nonsterile Semisolid Dosage... 

CMCCC, CDER, FDA. Guidance for Industry—Changes to an Approved NDA or ANDA. Drug Information Branch, CDER, FDA (November 1999). 

FDA guidelines for Scale-up and Postapproval Changes (SUPAC) and changes to an approved NDA or ANDA. 

Once a monograph is final, any drug within the category may be marketed only in compliance with the monograph or under an approved NDA [84], FDA does provide for an abbreviated form of NDA in which the drug would deviate in some respect from the monograph [85]. This so-called NDA deviation need include only information pertinent to the deviation [86],... 

To provide a context for our discussion of Rx-to-OTC switches, we will describe briefly the classifications of drugs that must be limited to prescription use. Specifically, the following types of drugs must be sold for prescription use only (1) drugs not safe for use except under the supervision of a licensed practitioner because of toxicity or other potential for harmful effect, method of use, or the collateral measures necessary for use and (2) drugs limited to prescription under an approved NDA [87]. FDA may remove by regulation a drug subject to the premarket approval requirements from prescription status when such requirements are not necessary for the public health [88]. 

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