Regulatory Guidance Monthly Review - May 2021

May 2021 


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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 May 2021.

 

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New FDA Guidance Documents:

 

Qualified Infectious Disease Product Designation – Questions and Answers – Guidance for Industry (published 11May2021)

Download FDA Guidance

 

S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals (published 11May2021)

Download FDA Guidance

 

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (published 11May2021)

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Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry (published 11May2021)

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S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals (published 11May2021)

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Q3D(R2) – Guideline for Elemental Impurities-Investigators (published 11May2021)

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E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials (published 11May2021)

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COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention (published 17May2021)

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Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers (published 17May2021)

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Bispecific Antibody Development Programs Guidance for Industry (published 20May2021)

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Emergency Use Authorization for Vaccines to Prevent COVID-19 (published 25May2021)

Download FDA Guidance

 

New Draft Guidance Documents:

 

Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators (published 11May2021)

Download Draft FDA Guidance

 

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) (published 17May2021)

Download Draft FDA Guidance

 

Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry (published 19May2021)

Download Draft FDA Guidance

 

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (published 20May2021)

Download Draft FDA Guidance

 

ICH Q12: Implementation Considerations for FDA-Regulated Products (published 20May2021)

Download Draft FDA Guidance

 


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

ICH announces sign-off of residual solvent guideline (published 03May2021)

Read Article on RAPS.org

 

BsUFA talks continue on technology, regulatory science and reviews (published 04May2021)

Read Article on RAPS.org

 

Panelists: Sluggish pace of DSCSA testing is worrisome (published 04May2021)

Read Article on RAPS.org

 

FDA welcomes alternative approaches to generic drug development (published 05May2021)

Read Article on RAPS.org

 

FDA tallies pandemic inspection toll, issues new 'resiliency roadmap' (published 05May2021)

Read Article on RAPS.org

 

Global regulators issue call for clinical trial data transparency (published 07May2021)

Read Article on RAPS.org

 

Shuren updates on inspections, ISO 13485 and MDUFA V (published 10May2021)

Read Article on RAPS.org

 

FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers (published 11May2021)

Read Article on RAPS.org

 

FDA finalizes QIDP Q&A guidance (published 11May2021)

Read Article on RAPS.org

 

Capacity adjustments, DMFs under discussion for GDUFA III (published 12May2021)

Read Article on RAPS.org

 

FDA calls for input on peptide evaluation (published 13May2021)

Read Article on RAPS.org

 

To speed drug development, ICH proposes reducing rat carcinogenicity testing (published 14May2021)

Read Article on RAPS.org

 

FDA: Flexibility okay for gaps in gene therapy trials (published 18May2021)

Read Article on RAPS.org

 

FDA clarifies potential actions when onsite inspections are infeasible (published 18May2021)

Read Article on RAPS.org

 

FDA clarifies deferral policy on pediatric studies for new cancer drugs (published 24May2021)

Read Article on RAPS.org

 

FDA may decline new COVID vaccine EUA requests (published 25May2021)

Read Article on RAPS.org

 

BsUFA III negotiations turn to supplements, technology proposals (Published 26May2021)

Read Article on RAPS.org

 


 

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