Food and Drug Administration

The AOA strives to provide its members with important information from the Food and Drug Administration (FDA) in a timely manner. The information below is organized into the following categories: Need to Know (drug approvals, recalls, and shortages), Good to Know (medication guides and guidance), and For Your Information (general information on proposed regulations, strategic priorities, and a sign-up service for specific FDA topics).

 

 NEED TO KNOW

 
Drug Approvals
  • Orange Book
    Lists approved drug products with therapeutic equivalence evaluations. The electronic Orange book is updated daily as new generic approvals occur. Page contains: link to publications, Frequently Asked Questions (FAQs) section, and ability to search by several categories including: active ingredient, applicant holder, proprietary name, application number, and patent.
  • New and Generic Drug Approvals
    Lists new and generic drug approvals alphabetically by date of action. Information includes: drug name, active ingredient, dosage form/route, sponsor, etc.
Drug Recalls
  • Recalls, Market Withdrawals, and Safety Alerts
    Press releases on recalled products issued within the last 60 days are listed on this page. The most recent release is at the top of the list. Press releases can be viewed in each product area – drugs, biologics, devices, etc. Individuals may also sign up for email notification for recalls, market withdrawals and safety alerts.
Drug Safety
  • Drug Specific Information
    Drugs listed have been the subject of a Healthcare Professional Information sheet, an Early Communication about an ongoing safety review, or other important information advisory. Drugs are listed alphabetically and are marked with a star (*) if there is an active FDA safety alert.
  • MedWatch
    MedWatch is the FDA’s Adverse Event Reporting Program. Information on page includes: ability to subscribe to MedWatch safety alerts, ability to report a serious medical product problem online, and individuals can sign up for the MedWatch email notification list.
Drug Shortages
  • Current Drug Shortages
    This is a listing of current drug shortages, including drug product name and reason for shortage. Information on drug shortages is provided voluntarily by manufacturers. Page also provides links to other information including: information for health professionals to report drug shortages, resolved drug shortages, drugs to be discontinued, and a Frequently Asked Questions (FAQs) page.
  • Drug Shortage Home Page
    Main (home) page for complete drug shortage information. Information includes: Administration’s Executive Order on Steps to Reduce Drug Shortages, Letter to Industry (Drug Manufacturers) regard drug shortages, and video, webcast, and podcast on the drug shortage issue. Individuals can also sign up for the drug shortage e-mail notification list.
 

 GOOD TO KNOW

 
Drug Medication Guides
  • FDA Medication Guides
    Information on medication guide handouts that are included with many prescription medicines. These guides are for specific drugs and drug classes and contain FDA-approved information which can assist patients in avoiding adverse events. This page contains a list of products for which medication guides are available
  • Medication Guides Guidance for Risk Evaluation and Mitigation Strategies (REMS)
    FDA guidance provides the agency’s current thinking on a topic. This guidance provides information to industry, health care providers, and authorized dispensers of prescription drugs and addresses when a medication guide will be required as part of a Risk Evaluation and Mitigation Strategy (REMS). FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biological product outweigh its risks.
  • Approved Risk Evaluation and Mitigation Strategies (REMS)
    This page lists the Risk Evaluation and Mitigation Strategies (REMS) that have been approved by the FDA. Information includes: name of the drug, date, and approved components (medication guide, elements to assure safe use, etc.)
 

 FOR YOUR INFORMATION

 
  • Proposed Regulations and Draft Guidance
    This page contains information on FDA draft regulations and guidance. Documents listed in this section are open for public comment. Information is provided in each document on how to submit comments to FDA.
  • Strategic Priorities
    This plan outlines the strategic priorities that will direct the agency’s work for the next five years and beyond. Key areas outlined include: key priorities, cross-cutting strategic priorities, program-specific strategic goals, and long term objectives.
  • News and Events
    This page provides direct links to FDA press releases. Press releases from 2004 to the present are included. Individuals may also sign up on this page to receive email notifications regarding FDA press release announcements.
  • Advisory Committee Information
    This page provides information regarding FDA advisory committees. Information includes an advisory committee calendar with a list of current posted meetings. Individuals can also sign up on this page to receive e-mail notifications on updates to advisory committee meetings.
  • Email sign up on specific FDA topics
    This page is for individuals to sign up to receive email updates on specific FDA topics through the agency’s email alert service.