Drug approvals, process

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

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

Reasons for chopping clinical candidates at any stage of the drug approval process included (1) stability, formulation, or other pharmaceutical development issues, (2) renal toxicity or neurotoxicity, and (3) insufficient advantage over current chugs. Since 1997, the NCI has also operated a screen for compounds active against the cytotoxic effects of HIV in CEM cells. Of 80,000 compounds tested, 4050 (or about 5%) were active. Of the compounds tested, 2291 have included metals. Of those, 136 (about 6%) were active, and two became clinical candidates. Both were chopped due to toxicity problems. One clinical candidate was a polyoxometallate, and therefore about 80 other similar molecules were tested. These were found to be strongly active in vitro, but too toxic in animal models in vivo. If a way around the toxicity problem can be found, interest in these... 

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

Section 8.7 explains the clinical trial and drug approval processes in Australia. 

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Pharmaceutical and Medical Device Agency (PMDA), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at the end of Phase II studies, before NDA, and consultation on individual protocols. 

An NDA submitted to the MHLW is reviewed by the PMDA. PMDA personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess comphance. In the process, the PMDA consults the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Results of the review are forwarded to the Pharmaceutical and Food Safety Bureau (PFSB), which prepares the final approval through the Minister of the MHLW. Figure 8.10 shows the drug approval process in Japan. The procedure for manufacturing and distribution of drugs for overseas manufacturers is presented in Fig. 8.11. 

Figure 8.12 Imported Western drug approval process in China.

In the United States the drug approval processes are as follows ... 

McMahon Commission Report. Commission on the Federal Drug Approval Process. Final Report 1982. 

All you would ever want to know about the drug approval process as well as basic information on diseases and current event topics. 

Wood AJ. A proposal for radical changes in the drug approval process. N Engl J Med 2006 355 618-23. 

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. 

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