Info

Fig. 3.18. Labeling Expansion

Fig. 3.18. Labeling Expansion facturing information and labeling. They are thousands of pages in many volumes for any one product application. A regulatory application will be filed for most products in all the three worldwide markets, USA (FDA), EU (EMEA), and Japan. Prior to human studies in the USA, an Investigational New Drug (IND) application is required to be filed with regulatory authorities. Labeling changes in the USA require a supplemental NDA document. Generic drug applications in the USA require an abbreviated NDA demonstrating pharma-cokinetic equivalence (bioavailability), assurance of the same ingredients, and manufacturing processes. Many European countries have dual sequential and separate approval processes; documents are required for the regulatory authority for safety and efficacy and then the pricing committee for approval of reimbursement for the product [6].

A pharmaceutical company performs many studies that are internal standard documents for company use, incorporated later as key parts of a regulatory submission, and are presented at scientific meetings, as shown in Figure 3.20 Each study will result in a statistical report, tables of data, and their statistical interpretations, and the final study clinical report, adding to the stat report all the clinical background, clinical interpretations, and conclusions. External presentations of the data are done by company clinicians and especially and more often by their university collaborators in two major settings; investigator meetings and medical society meetings. The presentations include written abstracts for posters at meetings,

Regulatory Bodies: FDA, EMEA, Countries, Japan

~IND (Investigational New Drug App) ~NDA (New Drug App)

~PLA (Product License App)

~sNDA (Supplemental New Drug App) -ANDA (Abbreviated NDA)

-IDE (Investigational Device)

-Pricing Committees (each country)

Fig. 3.19. Regulatory Applications

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Project Management Made Easy

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