Regulatory Guidance Monthly Review - September 2019

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October 2, 2019

September 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 September 2019.

 



FDA Updates


Draft Guidance icon

 

FDA has Finalized the Following Draft Guidance Documents:

 

 

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry (Published 30Sep2019)

https://www.fda.gov/media/123448/download

 

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry (Published 23Sep2019)

https://www.fda.gov/media/130964/download

 

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry (Published 23Sep2019)

https://www.fda.gov/media/131005/download

 

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Published 18Sep2019)

https://www.fda.gov/media/130878/download

 

Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry (Published 05Sep2019)

https://www.fda.gov/media/130449/download

 

Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers Guidance for Industry (Published 04Sep2019)

https://www.fda.gov/media/130451/download

 

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Guidance for Industry and Food and Drug Administration Staff (27Sep2019)

https://www.fda.gov/media/109622/download 

 

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and Food and Drug Administration Staff (Published 27Sep2019)

https://www.fda.gov/media/88572/download

 

Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (Published 27Sep2019)

https://www.fda.gov/media/80958/download

 

Safety and Performance Based Pathway Guidance for Industry and Food and Drug Administration (Published 20Sep2019)

https://www.fda.gov/media/112691/download

 

Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff (Published 13Sep2019)

https://www.fda.gov/media/83888/download

 

The Abbreviated 510(k) Program Guidance for Industry and Food and Drug Administration Staff (Published 13Sep2019)

https://www.fda.gov/media/72646/download

 

The Special 510(k) Program Guidance for Industry and Food and Drug Administration Staff (Published 13Sep2019)

https://www.fda.gov/media/116418/download

 

Humanitarian Device Exemption (HDE) Program Guidance for Industry and Food and Drug Administration Staff (Published 06Sep2019)

https://www.fda.gov/media/74307/download

 

Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designations Revision 1 to the final guidance issued on 24Jan2013 (Published 05Sep2019)

https://www.fda.gov/media/130442/download

 

 

NewGuidance_icon
FDA has Issued the Following New Draft Guidance Documents:

 

 

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders DRAFT GUIDANCE (Published 30Sep2019)

https://www.fda.gov/media/131230/download

 

Clinical Decision Support Software Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE (Published 27Sep2019)

https://www.fda.gov/media/109618/download

 

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products DRAFT GUIDANCE (Published 20Sep2019)

https://www.fda.gov/media/130897/download

 

Clinical Decision Support Software Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE (Published 27Sep2019)

https://www.fda.gov/media/109618/download

 

Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act Draft Guidance for Industry and Food and Drug Administration Staff (Published 26Sep2019)

https://www.fda.gov/media/131064/download

 

Patient Engagement in the Design and 2 Conduct of Medical Device Clinical 3 Investigations 4 5 Draft Guidance for Industry, 6 Food and Drug Administration Staff, 7 and Other Stakeholders (Published 24Sep2019)

https://www.fda.gov/media/130917/download

 

The Accreditation Scheme for 2 Conformity Assessment (ASCA) 3 Pilot Program 4 Draft Guidance for Industry, 5 Accreditation Bodies, Testing 6 Laboratories, and 7 Food and Drug Administration Staff (Published 23Sep2019)

https://www.fda.gov/media/130901/download

 

Safer Technologies Program for 3 Medical Devices 4 5 6 Draft Guidance for Industry and 7 Food and Drug Administration Staff (Published 19Sep2019)

https://www.fda.gov/media/130815/download

 

Format for Traditional and Abbreviated 510(k)s Guidance for Industry and Food and Drug Administration Staff (Published 13Sep2019)

https://www.fda.gov/media/130647/download

 

 

FDA News Update Icon

 

 FDA In The News: 

 

 

Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers (Published 30Sep2019)

https://www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers

 

Fees for Redeeming Priority Review Vouchers Fall to All-Time Low in FY2020 (Published 30Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/fees-for-redeeming-priority-review-vouchers-fall-t

 

Congress clears FDA to reorganize Office of New Drugs (Published 27Sep2019)

https://www.fiercebiotech.com/biotech/congress-clears-fda-to-reorganize-office-new-drugs

 

Cancer immunotherapy boom showing no sign of slowdown (Published 27Sep2019)

https://www.biopharmadive.com/news/cancer-immunotherapy-research-growth-drug-study-oncology/563881/

 

CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies (Published 28Sep2019)

https://www.ipqpubs.com/2019/09/28/cber-reviewers-are-working-with-sponsors-in-exploring-cmc-flexibility-for-cell-and-gene-therapies/

 

Sentinel: FDA Expands Initiative With Two New Centers (Published 30Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/sentinel-fda-expands-initiative-with-two-new-cent

 

MHRA Explains Exceptions and Modifications to EU GVP in No-Deal Brexit (Published 27Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/mhra-explains-exceptions-and-modifications-to-eu-g

 

Republicans Rebuke Pelosi Drug Pricing Bill (Published 25Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/republicans-rebuke-pelosi-drug-pricing-bill

 

EMA's CHMP Recommends Three New Medicines (Published 20Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/emas-chmp-recommends-three-new-medicines

 

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma (Published 17Sep2019)

https://www.fda.gov/news-events/press-announcements/fda-takes-first-action-under-new-international-collaboration-australia-and-canada-designed-provide

 

US Government Wants to Know More About the Biotech Ecosystem (Published 10Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/us-government-wants-to-know-more-about-the-biotech

 

Statement on improving adverse event reporting of compounded drugs to protect patients (Published 09Sep2019)

https://www.fda.gov/news-events/press-announcements/statement-improving-adverse-event-reporting-compounded-drugs-protect-patients

 

As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues (Published 04Sep2019)

https://www.raps.org/news-and-articles/news-articles/2019/9/as-the-race-for-a-permanent-fda-commissioner-picks

 


 

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