Prepare yourself for 2020 – Global regulatory update

With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

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Common Promotional Submissions in eCTD Errors and How to Avoid Them

Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP ...

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FDA at DIA RSIDM 2019 – Presentations Highlights

As part of the DIA RSIDM conference in Bethesda, ML in February 2019, the following comprehensive list summarizes our ...

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FDA has published a new guidance on eCTD 4.0

Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of ...

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FDA Working to Lift Barriers to Generic Drug Competition

On June 21, 2017, FDA communicated their intent to ensure that patients are not being priced out of the medicines they ...

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Information on new Technical Rejection Criteria (FDA) on Study Data

As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow ...

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