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Chief Medical Officer Summit -CMO 360°
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in December 2020.
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products (Final, 08 Dec 2020)
Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling (Final, 23 Dec 2020)
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products (Final, Dec 2020)
Best Practices in Developing Proprietary Names for Human Prescription Drug Products (Draft, 08 Dec 2020)
A deep dive into OPDP’s position on public health emergencies in the US
Q4 Regulatory Focus Article Series: Regulatory Intelligence
Preparing for advertising and promotion eCTD submissions in the US
What’s in the Brexit trade deal for the pharmaceutical and medical device industries?
Safer technologies program finalized by FDA (Devices)
FDA FY2021 user fee table
Coronavirus (COVID-19) Update: December 30, 2020
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Apr 9, 2024 Veristat Events
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
4 min read
Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...