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.
New FDA Guidance Documents:
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)
New Draft Guidance Documents:
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
- Learn about our Cell and Gene Therapy Center of Excellence
- Discover our expanded Pharmacovigilance service offering through the acquisition of Certus PV.
- Explore the Veristat COVID-19 Resource page
- Download our COVID-19 Guide on Strategies For Success During the COVID-19 Era
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER