To support the implementation of DPCO, 2013, the Integrated Pharmaceutical Database Management System (IPDMS) was developed.

Sooma announced that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation ...

As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.

A new bill would, if passed, force businesses that sell vaping products to have guidelines and regulations about what can be ...

THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...

If confirmed, Makary would run one of the nation's leading health agencies, overseeing the regulation of food and drugs.

Potential Medicare coverage reforms, such as eliminating Coverage with Evidence Development, would remove key policy tools ...

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with a particular emphasis on the more than 220 people in the FDA’s Center for Devices and Radiological Health. Staffers at the unit are responsible for reviewing and approving medical devices like ...

Srivastav highlighted the need for robust regulatory standards to ensure that only quality and effective medicines circulate nationwide. She also praised the work of the Central Drugs Standard Control ...

Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...