Regulatory Guidance Monthly Review - July 2019

Clinical Trial Regulations Regulatory Consulting Regulatory Submissions

July 2019 Updates from FDA

Veristat's March 2019 Review of FDA Regulatory Guidances and EMA updates 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 July 2019.

FDA Updates

FDA has Finalized the Following Draft Guidance Documents:

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

https://www.fda.gov/media/129320/download

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

https://www.fda.gov/media/111788/download

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

https://www.fda.gov/media/129126/download

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

https://www.fda.gov/media/128651/download

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)

https://www.fda.gov/media/128603/download

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FDA has Issued the Following New Draft Guidance Documents:

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

https://www.fda.gov/media/90014/download

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)

https://www.fda.gov/media/128793/download

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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmonizing-compendial-standards-drug-application-approval-using-usp-pending-monograph-process

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

https://www.fda.gov/media/128687/download

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)

https://www.fda.gov/media/128446/download