Regulatory Guidance Monthly Review - December 2020

December 2020 


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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.

 

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New FDA Guidance Documents:


Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products (Final, 08 Dec 2020) 

Download FDA Guidance 

 

Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling (Final, 23 Dec 2020) 

Download FDA Guidance 

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products (Final, Dec 2020) 

Download FDA Guidance 

 


New Draft Guidance Documents:

 

Best Practices in Developing Proprietary Names for Human Prescription Drug Products (Draft, 08 Dec 2020) 

Download DRAFT Guidance 

 


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

A deep dive into OPDP’s position on public health emergencies in the US 

Read Article on RAPS.org 

 

Q4 Regulatory Focus Article Series: Regulatory Intelligence 

Read Article on RAPS.org 

 

Preparing for advertising and promotion eCTD submissions in the US 

Read Article on RAPS.org 

 

What’s in the Brexit trade deal for the pharmaceutical and medical device industries? 

Read Article on RAPS.org 

 

Safer technologies program finalized by FDA (Devices) 

Read Article on RAPS.org 

 

FDA FY2021 user fee table 

Read Article on RAPS.org 

 

Coronavirus (COVID-19) Update: December 30, 2020 

Read FDA News Release 

 


 

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