Glossary

US FDA

What is FDA?

The United States Food and Drug Administration (US FDA) is a federal agency responsible for protecting and promoting public health through the regulation and supervision of food, tobacco, dietary supplements, cosmetics, pharmaceuticals, vaccines, biopharmaceuticals, blood transfusions, medical devices, and radiation-emitting electronic products. The FDA is responsible for ensuring that these products are safe, effective, and meet certain standards for quality and purity. The agency is also responsible for regulating the manufacturing, labelling, and marketing of these products, as well as monitoring their safety and efficacy after they are approved for use.

What are the key responsibilities of FDA?

  • Reviewing and approving new drugs, biologics, and medical devices before they can be marketed
  • Setting standards for food safety, quality, and labelling
  • Monitoring the post-market safety of products and acting if issues arise
  • Overseeing the manufacturing, marketing, and distribution of tobacco products
  • Monitoring adverse event reports and product complaints

How does FDA ensure safety of drugs?

The US Food and Drug Administration (FDA) ensures the safety of drugs through a rigorous process that involves several steps, including:

FDA’s Drug Safety Process:

  • Pre-Clinical Testing: The FDA reviews data from laboratory and animal studies to assess the drug’s potential safety and efficacy.
  • Investigational New Drug (IND) Application: The FDA reviews the IND application, which includes data from pre-clinical testing, to determine whether the drug can be tested in humans.
  • Clinical Trials: The FDA oversees clinical trials, which are conducted in three phases, to assess the drug’s safety and efficacy in humans.
  • New Drug Application (NDA) Review: The FDA reviews the NDA, which includes data from clinical trials, to determine whether the drug is safe and effective for approval.
  • Approval: The FDA grants approval for the drug to be marketed and sold in the United States if it meets the agency’s safety and efficacy standards.
  • Post-Market Surveillance: The FDA monitors the drug’s safety and efficacy after approval, through various mechanisms, including:
  • Adverse Event Reporting: The FDA collects and reviews reports of adverse events associated with the drug.
  • Pharmacovigilance: The FDA conducts ongoing safety monitoring and risk assessment to identify potential safety issues.
  • Labelling Changes: The FDA updates the drug’s labelling to reflect new safety information or warnings.
  • Inspections and Enforcement: The FDA conducts regular inspections of manufacturing facilities and takes enforcement action when necessary to ensure compliance with good manufacturing practices (GMPs) and other regulations.
  • Risk Evaluation and Mitigation Strategies (REMS): The FDA requires REMS for certain drugs to ensure that the benefits of the drug outweigh the risks.
  • Drug Safety Communications: The FDA issues safety communications to healthcare professionals and the public about potential safety issues with drugs.
  • Recalls and Withdrawals: The FDA works with manufacturers to recall or withdraw drugs from the market if they are found to be unsafe or ineffective.

How does the FDA handle drug recalls?

The FDA plays a crucial role in overseeing and managing drug recalls to ensure public safety. Drug recalls may be conducted voluntarily by the manufacturer or at the FDA’s request. The FDA’s role is to supervise and assess the adequacy of the company’s recall strategy and actions. They evaluate the appropriateness of the recall and classify it accordingly. The FDA also provides information to the public about drug recalls and how to handle them. It is important for pharmacists to be familiar with the FDA’s drug recall process to address patient concerns and ensure uninterrupted patient care.