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How Pharmaceuticals Make Their Way to Market: The FDA Approval Process and Patient Safety Concerns

The Food and Drug Administration (FDA) requires that all new pharmaceuticals travel a long path with several steps before being approved for use to treat illness and disease. The FDA requires new drugs to undergo this process for many reasons, primarily to discover if the drug does what it is meant to do and to learn of potentially harmful side effects. Most importantly, the underlying purpose of the FDA approval process is patient safety.

Typically, before a new drug is approved by the FDA, the drug manufacturer must complete several phases of testing. Often, before the drug can be tested on humans, it goes through preclinical testing (testing on animals). Once that is completed, several phases of testing the drug on humans can begin, but only after the FDA approves the proposal for human testing.

The FDA requires three phases of human trials, with each phase involving more people. During these testing phases, drug companies look for data on what and how harmful the drug's side effects are, if the drug does what it is intended to do, and how the drug interacts with other medications.

Yet, with all of the testing the FDA requires, dangerous drugs still are approved for use. Drug manufacturers can get a dangerous drug onto the market in several ways, including:

  • Not sufficiently testing the drug (rushing the drug to market)
  • Not fully disclosing known side effects
  • Marketing a drug for conditions not tested for while gaining FDA approval
  • Providing incentives to doctors to prescribe the drugs for conditions not tested for while gaining FDA approval (called off-label use)
  • Contamination during production

The injuries caused by taking a dangerous or defective drug can be devastating, even deadly. If you or a loved one has been injured by a dangerous drug, speak with an attorney experienced in handling injury claims caused by defective medical devices and dangerous drugs.

Contact Trolman, Glaser, & Lichtman, PC

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747 Third Avenue, 23rd Floor | New York, NY 10017
| Phone: 212-750-1200 | Toll Free: 1-888-484-5529 | Fax: 212-980-4011 | Email | New York Law Office

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Contact trolman, glaser & lichtman, PC

747 Third Avenue, 23rd Floor | New York, NY 10017|Phone: 212-750-1200|Toll-Free: 1-888-484-5529|Fax: 212-980-4011|Email