Regulatory Guidance Monthly Review - October 2019

October 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 October 2019.


FDA Updates

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FDA has Finalized the Following Draft Guidance Documents:



Electronic Submission of IND and Safety Reports Technical Conformance Guide (Published 30Oct2019)


Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidance for Industry (Published 22Oct2019)


Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (Published 16Oct2019)


Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review Guidance for Industry (Published 15Oct2019)


Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry (Published 09Oct2019)


Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus Guidance for Industry (Published 02Oct2019)


Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment Guidance for Industry (Published 02Oct2019)



FDA has Issued the Following New Draft Guidance Documents:



Providing Regulatory Submissions in Electronic Format: IND Safety Reports DRAFT GUIDANCE (Published 30Oct2019)


Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software DRAFT GUIDANCE (Published 28Oct2019)


Drug Products Labeled as Homeopathic DRAFT GUIDANCE (Published 24Oct2019)


Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE (Published 24Oct2019)


Drug Master Files DRAFT GUIDANCE (Published 18Oct2019)



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 FDA In The News: 




Evolving Global Regulatory Landscape, Strategies and Best Practices (Published 31Oct2019)


The new EU MDR and its impact on drug device combination products (Published 31Oct2019)


Senators Reiterate Concerns About FDA’s Software Pre-Cert Program (Published 30Oct2019)


FDA to Require Certain IND Safety Reports be Submitted to FAERS (Published 29Oct2019)


Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts (Published 29Oct2019)


EMA Lays Out Plans for Testing for Nitrosamine Impurities (Published 28Oct2019)


MDR/IVDR Guidance: MDCG Explains What’s Coming (Published 25Oct2019)


FDA Revises Guidance on Postmarketing Studies to Reflect ARIA System, SUPPORT Act (Published 24Oct2019)


FDA Tweaks its Approach to Homeopathic Products (Published 24Oct2019)


Global Regulatory Projects: Best Practices (Published 23Oct2019)


EMA Issues Guide on Consistency of Indication Wording (Published 21Oct2019)


Where are the Interchangeable Biosimilars? (Published 21Oct2019)


Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance (17Oct2019)


Practical Solutions to Pharmaceutical Labeling Challenges (16Oct2019)


Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA (Published 11Oct2019)


Researchers Find 15% of Trials Could be Replicated Using Real World Data (Published 10Oct2019)


N-of-1 Trials: FDA Plots Path to Regulation (Published 10Oct2019)


Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss (Published 07Oct2019)


FDA Unveils New Tables for Submitting Bioanalytical Methods (04Oct2019)


Label Restrictions After Accelerated Approval Impacts Use, Researchers Find (Published 02Oct2019)