Regulatory Guidance Monthly Review - July 2019

July 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 July 2019.


FDA Updates

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FDA has Finalized the Following Draft Guidance Documents:



Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention (Published 26Jul2019)


Post marketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff (Published 22Jul2019)


Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry-Technical Specifications Document (Published 18Jul2019)


Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry (Published 09Jul2019)


Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry (Published 05Jul2019)




FDA has Issued the Following New Draft Guidance Documents:



Manifestations  Guidance Rare Pediatric Disease Priority Review Vouchers (Published 30Jul2019)


Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information  (Published 23Jul2019)

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (Published 16Jul2019)


Population Pharmacokinetics Guidance for Industry (Published 11Jul2019)


Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry (Published 10Jul2019)


Using the Inactive Ingredient Database Guidance for Industry (Published 10Jul2019)


Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry (Published 01Jul2019)


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 FDA In The News: 



Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas (Published  31Jul2019)


USP, British Pharmacopoeia Formalize Quality Standards Partnership (Published 30Jul2019)


EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020 (Published 30Jul2019)


Industry Groups Support FDA’s Latest Biosimilar Analytic Assessment Guidance (Published 29Jul2019)


Rare Pediatric Disease PRVs: FDA Updates Guidance (Published 29Jul2019)


FDA Withdraws Guidance on Electronically Submitting Manufacturing Establishment Info (Published 29Jul2019)


Changing Global Regulatory Landscape and Strategy for Drug and Device Operations (Published 29Jul2019)


Australia Reacts to Potential Notified Body Shortages (26Jul2019)


FDA Finalizes Guidance on Delayed Graft Function in Kidney Transplantation (Published 26Jul2019)


Regulating Digital Health: Novartis CEO Seeks Further Modernization (Published 25Jul2019)


EU Regulatory Roundup: MHRA Finances Hit by Brexit-Triggered Drop in Income From EMA (Published 25Jul2019)


Transforming Regulatory Operations (Published 17Jul2019)