Regulatory Guidance Monthly Review - August 2019

August 2019 Updates from FDA 

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 August 2019.

FDA Updates

FDA has Finalized the Following Draft Guidance Documents:

Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry (Published 28Aug2019)

https://www.fda.gov/media/130326/download

Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry (14Aug2019)

https://www.fda.gov/media/129899/download

Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (13Aug2019)

https://www.fda.gov/media/129881/download

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry (01Aug2019)

https://www.fda.gov/media/129547/download

Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry (31Jul2019)

https://www.fda.gov/media/129530/download

Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry (31Jul2019)

https://www.fda.gov/media/129531/download

Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry (31Jul2019)

https://www.fda.gov/media/129537/download

FDA has Issued the Following New Draft Guidance Documents:

Male Breast Cancer: Developing Drugs for Treatment Guidance for Industry (Published 27Aug2019)

https://www.fda.gov/media/130061/download

Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry (13Aug2019)

https://www.fda.gov/media/129880/download

Fabry Disease: Developing Drugs for Treatment Guidance for Industry (07Aug2019)

https://www.fda.gov/media/129690/download

E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES (31Jul2019)

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry (31Jul2019)

https://www.fda.gov/media/129532/download

Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry (31Jul2019)

https://www.fda.gov/media/129533/download

 FDA In The News: 

FDA Probe Into Patient Infections Over Contaminated Duodenoscopes Hits Turning Point (Published 30Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/fda-probe-into-patient-infections-over-contaminate

EMA Offers Edits on FDA Draft Guidance on Biosimilars (Published 29Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/ema-offers-edits-on-fda-draft-guidance-on-biosimil

WHO Launches Registry for Gene Editing Studies (29Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/who-launches-registry-for-gene-editing-studies

EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit (Published 29Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/eu-regulatory-roundup-astrazeneca-gets-clearance

EC Cites Regulatory Controls for Medical Devices as US-EU Trade Barriers (published 07Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/ec-cites-regulatory-controls-for-medical-devices-a

Updated: FDA Reviewing Data Manipulation in Application for Novartis Gene Therapy Zolgensma (Published 06Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/fda-reviewing-data-manipulation-in-application-for

eCTD Submission Management (05Aug2019)

https://www.raps.org/news-and-articles/news-articles/2019/8/ectd-submission-management

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making (Published August 2019)

https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical

Global public meeting on draft ICH guideline on clinical trials (Published 30Aug2019)

 https://www.ema.europa.eu/en/news/global-public-meeting-draft-ich-guideline-clinical-trials

FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease. FDA Drug Safety Communication (Published 28Aug2019)

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrence-serious-liver-injury-use-hepatitis-c-medicines-mavyret-zepatier-and

Just the Stats, Ma’am: FDA Increases Inspections in Foreign Countries, Resulting in a Higher Rate of Enforcement Actions than Imposed on U.S. Facilities (Published 30Aug2019)

http://www.fdalawblog.net/2019/08/just-the-stats-maam-fda-increases-inspections-in-foreign-countries-resulting-in-a-higher-rate-of-enforcement-actions-than-imposed-on-u-s-facilities/

Laser-charged gold nanoparticles destroy prostate tumors in first-in-human study (Published 29Aug2019)

https://www.fiercebiotech.com/medtech/laser-charged-gold-nanoparticles-destroy-prostate-tumors-first-human-study

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US (Published 16Aug2019)

https://www.ema.europa.eu/en/news/emafda-analysis-shows-high-degree-alignment-marketing-application-decisions-between-eu-us

Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published (Published 31Jul2019)

https://www.ema.europa.eu/en/news/supporting-medicine-developers-generating-quality-data-packages-early-access-approaches-prime

Brexit-related guidance for companies

https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies

• Download our most recent Infographic explaining the Types of FDA Meetings with CDER and CBER
• Regulatory Affairs
• Regulatory Consulting
• Regulatory Approvals
• Agency Meetings Support
• Regulatory Publishing