Regulatory Guidance Monthly Review - November 2019

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November 2019 Updates from FDA 

Veristat's March 2019 Review of FDA Regulatory Guidances and EMA updatesEach 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 November 2019.


FDA Updates

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FDA has Finalized the Following Draft Guidance Documents:



Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry (Published 29Nov2019)


Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry (15Nov2019)



FDA has Issued the Following New Draft Guidance Documents:



Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products Draft Guidance for Industry (Published 27Nov2019)


CERTIFICATES OF CONFIDENTIALITY Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff DRAFT GUIDANCE (Published 22Nov2019)


Compounding Animal Drugs from Bulk Drug Substances Guidance for Industry Draft Guidance (Published 20Nov2019)


Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry DRAFT GUIDANCE (Published 20Nov2019)


Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry DRAFT GUIDANCE (Published 01Nov2019)


Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry DRAFT GUIDANCE (Published 01Nov2019)


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Regulatory Agencies In The News: 



Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient (Published 25Nov2019)


Asia Regulatory Roundup: China Opens Food and Drug Center of Excellence (Published 27Nov2019)


EMA to Implement Ombudsman’s Recommendations on Avoiding Bias (Published 26Nov2019)


FDA Approves 5 New Costly Drugs Well Ahead of PDUFA Dates (26Nov2019)


Developing Digital Drug Information Based on Real World Effectiveness Tests: What Patients Really Need (Published 26Nov2019)


Office of New Drugs (OND) Reorganization Continues Apace (Published 25Nov2019)


How to Request a Certificate of Confidentiality: FDA Unveils Draft Guidance (22Nov2019)


Brexit Costs EMA Almost €60M in 2019 (Published 21Nov2019)


NASEM Committee Calls to Expand Agreements Between Drug Regulators (21Nov2019)


Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings (20Nov2019)


FDA Nominee Hahn Faces Limited Opposition From Senate Committee (Published 20Nov2019)


WHO Drafts Guideline on Data Integrity for Pharmaceuticals (Published 19Nov2019)




EC Considers Amending Provision on Duplicate MAAs for Biologics (Published 18Nov2019)


FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports (Published 15Nov2019)


EMA Finalizes Clinical Development Guideline for New Gout Treatments (14Nov2019)


Big Data and its Impact on the Pharmaceutical Industry (Published 14Nov2019)


Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes (Published 13Nov2019)


FDA’s Project Orbis May Expand to Singapore and Switzerland (Published 12Nov2019)


EC Offers Further Clarity on Clinical Trial Regulation (12Nov2019)


Regulators’ advice can make a difference for faster patient access to highly innovative therapies (Published 12Nov2019)


WHO Commends Russian Response to Proposed Heritable Human Genome Editing (Published 08Nov2019)


ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry (Published 08Nov2019)


FDA-EMA-PMDA Officials Discuss Convergence on Antibacterial Drugs (Published 06Nov2019)


FDA Renames and Restructures Oncology Office (06Nov2019)


ICH Updates: What to Expect Through 2020 (Published 05Nov2019)