FDA-Approved Drug Restores

Clinical trials and FDA Approval

The Clinical Trials Database is a standardized dataset of information about the clinical studies and trials conducted in support of Premarket Approval (PMA). When complete, it will be able to be used by patients, healthcare providers, researchers and manufacturers to gain more knowledge about individual products.

The PMA Clinical Trials Database is abstracted from Premarket Approval (PMA) Summaries of Safety and Effectiveness data (SSED). It contains information regarding:

  • Marketing history of the device
  • Study design
  • Select demographics of study participants
  • Study follow-up
  • Study results

The documents on this page include:

  • A data dictionary that defines the data elements in the spreadsheet
  • A detailed description of the PMA Clinical Trials Database that is in development
  • A Sample Clinical Trials Database with data from 3 individual PMAs

PMA Clinical Trials Database

In the future, FDA plans to integrate clinical trials data with information from the TPLC Database. The list below contains two examples of how the data might be presented in the future. Please note that these documents are only examples and do not contain current information.

Philips AVENT Philips AVENT Baby Monitor with Temperature and Humidity Sensors and New Eco Mode
Baby Product (Philips AVENT)
  • 100% interference-free dect technology provides extra long range of up to 1,ft - new eco mode helps reduce energy consumption when monitoring baby from a shorter...
  • Temperature and humidity sensors
  • Soothing lullabies and nightlight comforts baby to sleep
  • Volume control and talk back two way communication at all times
  • Ultra small parent unit includes vibration mode

BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

Popular Q&A

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How long do clinical trials and fda approval for a vaccine take?

How long are phase II clinical trials?

A long time phase II is only the start of a new drug being tested there are several more before the FDA approves any drug for humans to use
I would say just for II till the doctors get the results they are looking for or the results they don't want to hear then they will have to move on..

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