New drugs, approval

What are the variations in pharmacokinetics and pharmacodynamics of new generation psychotropics in different ethnic and cultural groups Are clinical drug trial data from specific population subgroups required before new drug approval is given ... 

Total number of new drugs approved each year... 

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

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

In 1993, a significant advance in simplifying the procedures relating to drug marketing authorization applications in the EU was made. At that time, the legal basis of a new drug approval system... 

The pharmaceutical industry faces many challenges today. Despite an increase in research and development (R D) spending of more than 30 billion per year there has actually been a decline in new drugs approved by the FDA on a yearly basis, with fewer than 30 new drugs approved in 2001. The attrition rate is still exceedingly high, and only one in 1000 compounds that are developed actually makes it to the market and only one in 10 of those compounds is a commercial success (as defined by sales of over 500 million per year). Each compound today costs approximately 800 million... 

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... 

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

Cadden, S. (1999). New Drug Approval in Canada. Parexel, Waltham, MA. 

Review time. Prior to 1992, therapeutic gain was classified as type A, B, or C. Starting in 1992, priority and standard designation was used to represent therapeutic potential for new drug approvals. 

Pharmaceutical firms have to ensure that there is a pipeline of new and better drugs to return the substantial investments made. It is estimated that large pharmaceutical firms need 4-5 new drugs approved every year to maintain their premium positions. However, most firms are far short of this target, with only about 1-2 new drugs approved per year. Table 1.5 presents a snapshot of the number of new drugs being developed by US companies in 2006. 

A recommendation by the PDG to establish a harmonized procedure for stability to light was taken up by the EWG with Japanese participants responsible for a first draft of a guideline. A harmonized procedure emerged, again for the purpose of new drug approval. 

In 1962, amendments to the Federal Food, Dmg, and Cosmetic Act added a proof-of-efficacy requirement to new drug approvals before that time, the FDA approved drugs for safety only. As a result of the amendments, brand-name companies are required to prove that new drugs are safe and effective prior to FDA approvd. To prove safety and efficacy, brand-name companies are required to conduct tests on humans ( clinical trials ) and to submit those results to the FDA with their new drug application (NDA). 

Kaitin K, Cairns C. The new drug approvals of 1999, 2000, and 2001 drug development trends a decade after passage of the prescription Drug User Pee Act of 1992. Drug Information Journal 2003 4 357-71. 

There are many forms of new prescription drugs, including NME, new formulation, new combination, new indication, and new manufacturer. This chapter discuss new drugs in the form of NMEs only. During the period 1990-2004, NMEs account for about one-third of the total new drugs approved by U.S. Food and Drug Administration (FDA). For details, see the FDA Web site (www.fda.gov/cder/rdmt/pstable.htm). 

The latter has been created both by the abovementioned slump in new drug approvals and the megamergers in the industry. In-house manufacturing usually gets the right of hrst refusal for the manufacture of APIs. For new production, outsourcing is not even considered old products that have been sourced from third parties are taken back in-house. 

Government pressure on healthcare costs and Fourth hurdle for new drug approvals... 

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