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  5. Step 5: FDA Post-Market Drug Safety Monitoring
  1. The Drug Development Process

Step 5: FDA Post-Market Drug Safety Monitoring

Even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval. Despite the rigorous steps in the process of drug development, limitations exist. Therefore, the true picture of a product’s safety actually evolves over the months and even years that make up a product’s lifetime in the marketplace. FDA reviews reports of problems with prescription and over-the-counter drugs, and can decide to add cautions to the dosage or usage information, as well as other measures for more serious issues.

On this page you will find information on:

Supplemental Applications

Developers must file a supplemental application if they wish to make any significant changes from the original NDA. Generally, any changes in formulation, labeling, or dosage strength must be approved by FDA before they can be made.

INDs for Marketed Drugs

If sponsors want to further develop an approved drug for a new use, dosage strength, new form, or different form (such as an injectable or oral liquid, as opposed to tablet form), or if they want to conduct other clinical research or a post-market safety study, they would do so under an IND.

Manufacturer Inspections

FDA officials conduct routine inspections of drug manufacturing facilities across the United States, and abroad if approved products are manufactured overseas. Manufacturers may be informed of inspections in advance, or the inspections may be unannounced. Inspections may be routine or caused by a particular problem or concern. The purpose of these inspections is to make sure that developers are following good manufacturer practice. FDA can shut down a facility if minimum standards are not met.

Drug Advertising

FDA regulates prescription drug advertisements and promotional labeling. By law, a developer is prohibited from advertising unapproved uses of their product.

All advertisements, such as product claims or reminder ads, cannot be false or misleading. They must contain truthful information about a drug’s effectiveness, side effects, and prescribing information. These advertisements can be found in medical journals, newspapers, and magazines, and on the Internet, television, or radio.

Promotional labeling differs from drug advertisements in the way it is distributed. Pharmaceutical companies give out brochures or other promotional materials to physicians or consumers. The drug’s prescribing information must accompany promotional labeling. Learn more at Prescription Drug Advertising.

Generic Drugs

New drugs are patent protected when they are approved for marketing. This means that only the sponsor has the right to market the drug exclusively. Once the patent expires, other drug manufacturers can develop the drug, which will be known as a generic version of the drug. Generic drugs are comparable to brand name drugs and must have the same:

  • Dosage form

  • Strength

  • Safety

  • Quality

  • Performance characteristics

  • Intended use

Because generic drugs are comparable to drugs already on the market, generic drug manufacturers do not have to conduct clinical trials to demonstrate that their product is safe and effective. Instead, they conduct bio-equivalence studies and file an Abbreviated New Drug Application. Learn more at Generic Drugs: Questions and Answers.

Reporting Problems

FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved drugs.

  • MedWatch is a gateway for reporting problems with medical products (drugs and devices) and learning about new safety information. You can subscribe to regular MedWatch safety alerts.

  • Medical Product Safety Network (MedSun) monitors the safety and effectiveness of medical devices. FDA recruits 350 healthcare providers throughout the United States to report any medical device problems that result in serious injury or death. Each month, FDA publishes the MedSun newsletter. The newsletter gives consumers important information about medical device safety.

Active Surveillance

Under the Sentinel Initiative, FDA is developing a new national system to more quickly spot possible safety issues. The system will use very large existing electronic health databases—like electronic health records systems, administrative and insurance claims databases, and registries—to keep an eye on the safety of approved medical products in real time. This tool will add to, but not replace, FDA's existing postmarket safety assessment tools. Learn more about the Sentinel Initiative and its major activities.

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