USA, FDA finalized their guidance on 510(k) third party review program (3P510k)

This guidance provides details on how types of devices are eligible for third party review and explain how third-party review …

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USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs)

USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs). CGTs designation was created …

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USA, FDA launched Guidance Snapshots

A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots. These new Guidance …

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USA, FDA’s launch of purple book, an online database for biologics

The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database …

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FDA to study Social Media Giant “Instagram” influencers and their disclosures.

It is confirmed that 2 studies would take place mainly focusing on Instagram influencers and how their audience perceive what …

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USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA. Upcoming in the later part of 2020, we …

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