New Drug Applications approval

Hynes, M.D. III. Introduction to food and drug administration pre-new drug applications approval inspections. Hynes, M.D. Ill (ed.). Preparing for FDA Pre-Approval Inspections. New York Marcel Dekker, 1998 pp. 1-10. 

Of all the new drug applications approved by the FDA between 1989 and 2000, by the estimate of the National Institute for Health Care Management (NIHCM), only one-third contained new active ingredients that could—even by a generous description—be considered innovative. (The pharmaceutical industry challeges the objectivity of the NIHCM, a nonprofit foundation, because it is heavily funded by the insurance industry, which has a natural bias toward low drug prices.)... 

Main offices related to new drug application, approval review, drug safety issues, reexamination and re evaluation are as follows. 

Additionally, the issuance of guidelines for pre- and post-New Drug Application approval inspections do provide, as the title suggests, guidance to the field inspector (and the pharmaceutical industry) on what should be addressed in the product development report (2,3). These considerations include the characterization of the final blend of the granulation and establishment of specifications to be used in the validation study. Establishing finished product specifications and in-process requirements are among the most important and critical steps in prod-... 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

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. 

Assurance that investigators will be notified if a new drug application is approved or the studies discontinued... 

B. Drug Information from Phase I, II, and III Studies, The New Drug Application, and Product Approval/Launch... 

Proposal to Withdraw Approval of Two New Drug Applications and One Abbreviated New Drug Application Terfenadine, Hoechst Marion Rousssel, Inc and Baker Norton Pharmaceuticals, Fed Regist., Docket No. 96N-0512, 1997, 1998. Part 216 Pharmacy Compounding, Drug Products Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness, Cite 216.24. 

The dossier submitted to the CDER is known as a new drug application (NDA), which, if approved, allows the drug to be marketed. If the drug is a CBER-regulated one, then a biologies licence application (BLA) is submitted. 

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... 

Content and format of an abbreviated application Refusal to approve an abbreviated new drug application... 

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