Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new drugs.
- Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent.
- The information in the Snapshots also highlights where the trials were conducted and whether there were any differences in the benefits and side effects among different demographic groups.
HOW TO READ SNAPSHOTS
Each Snapshot contains information about the drug in a question and answer format. Each Snapshot contains a "MORE INFO" section for more detailed and technical content.
- Consumer information is presented first.
- At the end of each consumer section of the Snapshot, there is a shaded bar with the words "MORE INFO". This section is for anyone interested in additional information. Click the "MORE INFO" bar for more technical and detailed content including data.
- At the beginning and at the end of each Snapshot, there is a link to the drug’s Prescribing Information (formerly known as the Package Insert).
LIMITATIONS OF SNAPSHOTS
The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. Do not rely on Snapshots alone to make decisions regarding medical care.
- Snapshots are not a substitute for advice from your health care professional.
- Snapshots aim to present differences in how well the drug works and side effects among different demographic groups. Conclusions regarding these differences cannot always be made.
FREQUENTLY ASKED QUESTIONS
Are all approved drugs presented in Snapshots?
No. Snapshots are published only for approved New Molecular Entities (NMEs) and original biologics. NMEs and original biologics are medications made of new molecular structures that have not been approved by the FDA before. The Snapshots program began in 2015 and reflects drugs approved after that time.
Are individual Snapshots updated?
No. The snapshots are published within 30 days of approval and contain information that was available at the time of approval.
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