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


Draft Guidance icon

 

FDA has Finalized the Following Draft Guidance Documents:

 

 

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

https://www.fda.gov/media/128419/download

 

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

https://www.fda.gov/media/128163/download

 

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

https://www.fda.gov/media/128127/download

 

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

https://www.fda.gov/media/126910/download

 

 

NewGuidance_icon
FDA has Issued the Following New Draft Guidance Documents:

 

 

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

https://www.fda.gov/media/128372/download

 

E19 OPTIMISATION OF SAFETY DATA COLLECTION (Published 26JUN2019)

https://www.fda.gov/media/128313/download

 

M10 BIOANALYTICAL METHOD VALIDATION (Published 26JUN2019)

https://www.fda.gov/media/128343/download

 

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

https://www.fda.gov/media/127712/download

 

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

https://www.fda.gov/media/127738/download

 

 

FDA News Update Icon

 

 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)

https://www.fda.gov/news-events/press-announcements/statement-stem-cell-clinic-permanent-injunction-and-fdas-ongoing-efforts-protect-patients-risks

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/fda-launches-expanded-access-pilot-project-facili

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/house-committee-questions-fda-on-foreign-drug-manu

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/pfizer-appoints-gottlieb-to-board-of-directors

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/fda-proposes-new-rule-on-allowing-the-use-of-dmfs

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/germany-joins-eu-us-gmp-mutual-recognition-pact

https://www.ema.europa.eu/en/news/one-additional-country-benefit-eu-us-mutual-recognition-agreement-inspections

https://www.ema.europa.eu/en/news/two-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections-1

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/eu-regulatory-roundup-trade-group-warns-preparing

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/fda-consults-on-ich-safety-data-bioanalytical-met

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/another-notified-body-bows-out-ahead-of-eu-mdr-i

 

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

https://www.raps.org/news-and-articles/news-articles/2019/6/fda-to-explore-randomized-trials-using-rwe-for-reg

 

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

https://www.fiercebiotech.com/medtech/fda-shutters-its-alternative-device-report-database-disclosing-20-years-safety-data

 

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

https://www.fiercebiotech.com/biotech/orkambi-debate-u-k-revives-myth-a-people-s-funded-drug

 

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

https://www.fiercebiotech.com/cro/massive-bio-ibm-watson-and-others-team-up-biden-cancer-initiative-for-oncology-tests-work

 

 


 

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