New drug approval process

New Drug Approval Process Clinical and Regulatory Management,... 

New Drug Approval Process Second Edition, Revised and Expanded, edited by Richard A. Guarino... 

Guarino, R.A. (1987). New Drug Approval Process. Marcel Dekker, New York. 

Authorities in many countries no longer accept high prices for new drugs with only a marginal therapeutic benefit improvement the British NICE" already has included economic considerations in their new drug approval process the FDA and EMEA might follow suit... 

Class III devices, unless they are substantially equivalent to a device already marketed without a PMA application, require formal FDA approval through the PMA process before initial sale. The PMA process is comparable to the new drug approval process (18). In both cases, safety and effectiveness data must be reviewed by FDA prior to marketing. An approved PMA application acts like a private license granted to the applicant to market a particular device. Other firms seeking to market the same type of device for the same use must also have an approved PMA. 

Guarino RA New drug approval process. In Drugs and The Pharmaceutical Sciences, vol. 100. Marcel Dekker, 2000. 

Agency s goal is to have its entire New Drug Approval Process take one year between the primary meeting with the sponsor and PMDA approval. 

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