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FDA Approval

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials.

FDA 510(k) Submissions for Obtaining FDA Approval (Clearance)

As many as 90 percent of the medical devices on the market in the United States have been through the 510(k) process.

The 510(k) section of the Food, Drug and Cosmetics Act requires a company to notify the FDA of its intent to market a new...

Contributor: Pharma IQ
Mon, 12/12/2011
FDA Compliance: Minimising Risk

Compliance with Food and Drugs Administration (FDA) guidelines is essential for all working within the pharmaceutical industry, from researchers working on clinical trials to those marketing the drugs to members of the public. The FDA is tasked...

Contributor: Pharma IQ
Wed, 11/17/2010
Pharma IQ

The pharmaceutical industry in the United States has to comply with a number of guidelines to ensure the quality of the products it manufactures, the safety of its workers and members of the public, and the environment in which it operates. Many...

Contributor: Pharma IQ
Sun, 09/19/2010