Approved new drug applications

A statement of each method used in the testing of the sample. The statement shall 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 employed is in the current revision of the United States Pharmacopeia, National Formulary, Association of Official Analytical Chemists, Book of Methods, or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use. 

FDA approval New Drug Application Must conform to OTC Not required for truthful Not required for Not required for Not required for... 

Exclusivity provides the holder of an approved new drug application limited protection from new competition in the marketplace for the innovation represented by its approved drug product 5 years for NCE, 3 years for new indication of approved NCE. 

The many essential steps in the discovery and development of new drugs can be measured by two primary benchmarks. The first, the number of filed and approved investigational new drag (IND) applications, represents the threshold to human (clinical) testing. The second, the number of filed and approved new drug applications (NDAs), represents the threshold to marketing a drug. These numbers and their trends can represent the relative success of R D efforts. 

An IND is a request for FDA authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application. 

As shown in Fig. 10, the preferred lubricant is No. 1 as it results in a smaller ejection force. Early lubricant studies are a must. When lubricant problems occur later on in the scale-up process, corrective measures not only require additional materials and development time, but may also require a supplement of an approved new drug application (NDA). 

FDA Performance Reports for the Prescription Drug User Fee Act. URL http //www.fda.gov/oc/pdufa/reports.html. Appendices to these annual reports include retrospective lists of approved new drug applications and their review times (time elapsed from initial submission to final authorization). 

Changes to Approved New Drug Applications or Abbreviated New Drug Applications... 

Predistribution clearance was required for safety of new drugs (approved New Drug Application) prior to the manufacturers commercial distribution. 

Any over-the-counter (OTC) drug product labeled or promoted for external use as a hair grower or for hair loss prevention is regarded as a new drug and must be the subject of an approved new drug application (NDA). Products making these claims without an NDA are considered to be in violation of the Federal Food, Drug and Cosmetic Act and are also mislabeled. 

The Food and Drug Administration approved New Drug Applications for use of butaperazine dimaleate, fluphenazine enanthate, haloperidol and thiothixene in treating schizophrenia. 

---