FDA drug approval process

Thalidomide, a new sedative, was associated with birth defects in thousands of newborns throughout Europe. Fortunately, the medication had not been approved for use within the U.S. In 1962, with the support of Senator Estes Kefauver, another health policy window was opened the amendments were passed to ensure that medications were both safe and efficacious. With the Kefauver-Harris Amendments, the effectiveness of a medication has to be proven by substantial evidence which includes adequate and well-controlled trials. For the first time, pharmaceutical manufacturers had to demonstrate a product s efficacy to the FDA. The Kefauver-Harris Amendments led the way for randomized clinical trials and the FDA drug approval process. 

Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act of 1938 Required medications to demonstrate their safety and effectiveness Created the FDA drug approval process Required randomized clinical trials for medications... 

Buc NL, Hutt PB (1988) Recent Changes in the FDA Drug Approval Process for Drugs and Biologies Where We Have... 

Structurally the FDA drug approval process closely resembles the food additive model of food safety. A manufacturer that wishes to market a new drug submits a petition to FDA,... 

The FDA s approval process for new prescription drugs is extensive. It can take over ten years for a drug to reach the market. Before receiving FDA approval, a new drug must be studied extensively. The process begins with the discovery or development of a new substance that can be used for medicinal purposes. The potential drug is first studied in a laboratory, then in animals. It is then studied in healthy adults to see what... 

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. 

In an effort to speed up the drug approval process, the U.S. FDA created a special "fast-track" system for agents that show unusual promise... 

The EU drug approval process is working toward a harmonized FDA-type system. The transformation is not yet complete, however, and currently the EU has two drug approval systems in place. 

In reality, proving safety in clinical trials for FDA drug approval is an even more flawed process than proving efficacy. Often, serious and even fatal reactions will not be detected in the studies used for drug approval. 

FDA Letter to Industry. FDA letter describing efforts by CDER and ORA to clarify responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication and redundancy. October 14, 1994. 

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