Regulatory Guidance Monthly Review - March 2020

March 2020 

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 in March 2020.

Finalized Draft Guidance Documents:

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry (Published 27Mar2020)

Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry (27Mar2020)

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards (27Mar2020)

Policy for Certain REMS Requirements During the COVID19 Public Health Emergency Guidance for Industry and Health Care Professionals (Published 22Mar2020)

Competitive Generic Therapies Guidance for Industry (Published 16Mar2020)
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Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Result From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry (Published 16Mar2020)
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Biological Product Deviation Reporting for Blood and Plasma Establishments Guidance for Industry (Published 12Mar2020)
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Q3D(R1) Elemental Impurities Guidance for Industry (Published 10Mar2020)

Safety Testing of Drug Metabolites Guidance for Industry (Published 05Mar2020)
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 The “Deemed To Be a License” Provision of the BPCI Act Questions and Answers Guidance for Industry (Published 04Mar2020)
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New Draft Guidance Documents:

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry DRAFT GUIDANCE (Published 17Mar2020)
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Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry DRAFT GUIDANCE (Published 11Mar2020)
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Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry DRAFT GUIDANCE (Published 10Mar2020)
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Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry DRAFT GUIDANCE ( Published 06Mar2020)
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Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry DRAFT GUIDANCE (Published 06Mar2020)
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Coronavirus (COVID-19) Update: Daily Roundup March 31, 2020
Read FDA News Release 

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 (Published 31Mar2020)
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COVID-19 Therapeutics Tracker (Published 31Mar2020)
Open RAPS Tracker

Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 (Published 30Mar2020)
Read FDA News Release

 Responding to Serious or Persistent Noncompliance (Published 30Mar2020)
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Key Concepts to Enhance Regulatory Communication and Ethics in the Current Environment (Published 27Mar2020)
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 Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (Published 27Mar2020)
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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes (Published 26Mar2020)
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FDA Ends CSR Pilot, Plots New Approach for Disclosing Study Reports (Published 26Mar2020)
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 Coronavirus Relief Bill Includes OTC Drug User Fee Program (Published 26Mar2020)
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 MHRA: Managing clinical trials during Coronavirus (COVID-19)  (Published 24Mar2020)
Read MHRA Guidance

 Health Canada-Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors (Published 23Mar2020)
Read Health Canada Guidance

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers (Published 24Mar2020)
Read FDA News Release

 Global regulators map out data requirements for phase 1 COVID-19 vaccine trials (Published 24Mar2020)
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BPCIA Turns 10: Nearly 100 Drugs Become Biologics (Published 23Mar2020)
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Coronavirus (COVID-19) Update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency (Published 22Mar2020)
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CBER Pauses Lot Release Activities Due to Coronavirus (Published 20Mar2020)
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FDA to Implement All COVID-19-Related Guidance Immediately, Without Public Comment (Published 20Mar2020)
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FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic (Published 20Mar2020)
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 MHRA guidance on Coronavirus (COVID-19) (Published 19Mar2020)
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Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments (Published 19Mar2020)
Read EMA News Release

Improving Communication with Health Authorities Throughout the eCTD Submission Process (Published 19Mar2020)
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CDER Kicks Off Final Phase of OND Reorganization (Published 18Mar2020)
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Drugmakers, Canadians Balk at FDA’s Safe Importation Plan (Published 16Mar2020)
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US Biosimilar Launches About to Turn a Corner (Published 16Mar2020)
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 HHS Provides Liability Shield for Coronavirus Countermeasures (Published 13Mar2020)
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 COVID-19: developers of medicines or vaccines to benefit from free scientific advice (Published 13Mar2020)
Read EMA News Release

 COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020 (Published 11Mar2020)
Read EMA News Release 

Coronavirus: WHO Declares Pandemic, EMA Meetings go Virtual (Published 11Mar2020)
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 Preparing for High-Stakes Regulatory Meetings in the US and Europe (Published 11Mar2020)
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 Global Orphan Drug Regulation (Published 10Mar2020)
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House Committee Wants FDA Briefing on Marketing Status Reporting Requirements (Published 09Mar2020)
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EU Regulatory Roundup: UK Calls for Mutual Recognition of GMP Certificates in Brexit Negotiation Plan (Published 05Mar2020)
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EMA Explains Unique Implementation of ICH Q12 Guideline (Published 04Mar2020)
Read EMA News Release

 Adopting Regulatory Intelligence Strategies to Foster the Evolving Landscape (Published 04Mar2020)
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 EMA organisational changes come into effect (Published 02Mar2020)
Read EMA News Release

• Explore the Veristat COVID-19 Resource page 
• 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
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