Regulatory Guidance Monthly Review - June 2019

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July 10, 2019

June 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 June 2019.


FDA Updates

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FDA has Finalized the Following Draft Guidance Documents:



Epidermolysis Bullosa:  Developing Drugs for Treatment of Cutaneous Manifestations  Guidance for Industry (Published 28JUN2019)


Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs  Guidance for Industry (Published 21JUN2019)


ANDA Submissions —  Content and Format  Guidance for Industry (Published 12JUN2019)


Revision 1 to Formal Dispute Resolution:  Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff  Good Review Practice (Published 30MAY2019)



FDA has Issued the Following New Draft Guidance Documents:



Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry (Published 27JUN2019)






Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (Published 06JUN2019)


Nonalcoholic Steatohepatitis with Compensated Cirrhosis:  Developing Drugs for Treatment Guidance for Industry (Published 06JUN2019)



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 FDA In The News: 



Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products (Published 25JUN2019)


FDA Launches Expanded Access Pilot ‘Project Facilitate’ (Published 03JUN2019)


House Committee Questions FDA on Foreign Drug Manufacturing Inspections (Published 28JUN2019)


Pfizer Appoints Gottlieb to Board of Directors (Published 28JUN2019)


FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics (Published 27JUN2019)


Additional Countries to benefit from EU-US mutual recognition agreement (Published Jun2019)


EU Regulatory Roundup: Trade Group Warns Preparing UK for October No-Deal Brexit is ‘Impossible’ (Published 27JUN2019)


FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines (Published 26JUN2019)


Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’ (Published 18Jun2019)


FDA to Explore Randomized Trials Using RWE for Regulatory Purposes (Published 07JUN2019)


FDA shutters its alternative device report database, disclosing 20 years of safety data (Published 24JUN2019)


Orkambi debate in U.K. revives the myth of a people-funded drug (Published 11JUN2019)


Massive Bio, IBM Watson, others team up with Biden Cancer Initiative for oncology work (Published 04JUN2019)