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CDER Report on Clinical Trials Global Participation

[ Price : $8.95]

CDER posts a report on Global Participation in Clinical Trials: 2015-2019 that summarizes the Centers Drug Trials Snapshot program...

Guidance on Drug Compounding Insanitary Conditions

[ Price : $8.95]

Federal Register notice: FDA releases a final guidance describing insanitary conditions at drug compounding facilities.

Guide on Assessing Drug User Fees

[ Price : $8.95]

FDA posts a final guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.

Guidance on Improving Clinical Trial Diversity

[ Price : $8.95]

FDA publishes a final guidance on Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, Enrollment Practice...

Guide on Microneedling Product Regulatory Considerations

[ Price : $8.95]

FDA issues a final guidance discussing when a microneedling product is a device for regulatory purposes.

Certificate for Devices Not Exported from U.S.

[ Price : $8.95]

FDA implements a certification program for medical devices not exported from the U.S.

Guide on Insanitary Conditions at Compounding Facilities

[ Price : $8.95]

FDA releases a final guidance on Insanitary Conditions at Compounding Facilities.

Sanhwa Biosciences Silmitasertib Study Proceeding

[ Price : $8.95]

Senhwa Biosciences says its clinical partner, Center for Advanced Research and Education, has received a study-may-proceed letter ...

Covid-19 Helps Advance RWE at FDA: Attorneys

[ Price : $8.95]

Attorneys from Hogan Lovells opine that the Covid-19 emergency has had the unintended consequence of cementing the use of real-wor...

Sedor Pharma Sesquient OKd for Status Epilepticus

[ Price : $8.95]

FDA approves a Sedor Pharmaceuticals NDA for Sesquient (fosphenytoin sodium for injection) for treating status epilepticus in adul...