Regulatory Guidance Review - May 2019

May 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)  and European Medicines Agency (EMA) 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 May 2019.


FDA Updates

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FDA has Finalized the Following Draft Guidance Documents:



Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide (Published 24May2019)


Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (Published 21May2019)


Considerations in Demonstrating Interchangeability With a Reference Product  (Published 09May2019)


Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry (Published 09May 2019)


Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry (Published 09May2019)


Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis (Published 09May2019)


Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The - Counter Monograph: Study Elements and Considerations (Published 09May2019)


FDA has Issued the Following New Draft Guidance Documents:



Clinical Lactation Studies: Considerations for Study Design Guidance for Industry (Published 08May2019)


Postapproval Pregnancy Safety Studies Guidance for Industry (Published 08May2019)


Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics (Published 08May2019)


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 FDA In The News: 



FDA’s First Hearing on CBD Opens a Path to Regulation (Published 31May2019)


Recon: China Approves Third Domestic PD-1 Drug; Fosun Rethinking US Deals Amid Trade Tensions (Published 31May2019)


Right to Try One Year Later: Limited Patient Involvement but More FDA Clarity Coming (Published 30May2019)


FDA Officials Call for Patient-Friendly Terminology in Oncology (29May2019)


ASCO 2019 preview: Big Pharmas looking for cancer R&D revival as we hit next-gen crossroads (Published 31May2019)