Resources for Assessing Drug Risks and Benefits
Summary
FDA's Center for Drug Evaluation and Research (CDER) published a resource page consolidating links to drug safety information tools, including Drug Safety Communications, MedWatch adverse event reporting, Drug Alerts and Statements, and post-market safety resources. The page also provides access to FDA drug databases (Drugs@FDA, Orange Book, Drug Shortages, NDC Directory), FDALabel, compounding information, and medication error resources. Contact information for the Division of Drug Information is provided for healthcare professionals seeking additional guidance.
“Drug Safety Information is data and resources that assess the potential risks and benefits of medications.”
About this source
GovPing monitors FDA Recent Drug Approvals for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 2 changes logged to date.
What changed
FDA published a consolidated resource page listing available drug safety information tools and databases maintained by CDER. The page organizes resources under categories including Drug Safety Communications, MedWatch (adverse event reporting), Drug Alerts and Statements, Post-Market Drug Safety, drug databases (Drugs@FDA, Orange Book, Drug Shortages, NDC Directory), FDALabel, compounding information, medication error resources, and FDA Drug Safety Podcasts.
Healthcare professionals and patients can use these resources to access safety monitoring data, reported side effects, clinical trial results, and emergency preparedness information related to FDA-regulated medications. The page serves as a navigational hub rather than imposing new compliance obligations.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Drug Safety Information is data and resources that assess the potential risks and benefits of medications. The FDA plays a crucial role in ensuring this information is accurate, comprehensive, and readily available to both health care professionals and the public.
Drug Safety Communications
Drug Safety Communications
Stay up to date on new safety issues with the medicines to make more informed decisions about treatment.
MedWatch
MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.
Drug Alerts and Statements
Review recent critical drug safety issues ranging from new side effects to problems in drug manufacturing.
Post-Market Drug Safety
Access resources for safety monitoring and the latest safety information for medications after they've been approved for public use.
Drug Databases
Search FDA's databases, including Drugs@FDA, Orange Book, Drug Shortages, and NDC Directory, for up-to-date drug information.
FDALabel
The FDALabel database offers detailed drug labels for FDA-approved medications, including reported side effects and clinical trial results.
Compounding
Get health care professional-specific information on compounded drugs, which can serve as a tool for patients lacking FDA-approved options.
Medication Errors
Glean insight into the FDA's role in minimizing medication errors caused by issues related to the design, labeling, and packaging of FDA-approved drugs.
Emergency Preparedness
Review the essentials of emergency preparedness related to medications including having a plan in place for storing and securing medications during disasters.
FDA Drug Safety Podcasts
Listen in on emerging safety information about drugs, in conjunction with the release of Drug Safety Communications, produced by CDER.
Paragraph Header For More Human Drug Information
Contact Point Division of Drug Information
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993
Toll Free (855) 543-3784 (301) 796-3400
Hours Available
Center for Drug Evaluation and Research (CDER)
- ## Content current as of:
07/10/2024
Regulated Product(s)
- Drugs
Mentioned entities
Related changes
Get daily alerts for FDA Recent Drug Approvals
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FDA Recent Drug Approvals publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.