FDA News & Views: CDRH Accomplishments and Priorities, Clinical Trial Information Transparency, Expediting Military Products, Supervisory Review of CDRH Decisions, Complex Generic Drugs, Enforcement Reports, Compounding Priorities, Orally Inhaled and Nasal Drug products – Drug and Device Digest

FDA BRIEF: Week of January 15, 2018


Capture.JPGCDRH 2016-2017 Accomplishments and 2018-2020 Strategic Priorities 

Achievement of strategic priorities for 2016-2017

  • National Evaluation System for Medical Devices (NEST): Framework for the incorporation of real-world evidence into regulatory decision making
  • Partner with Patients: Established Patient Engagement Advisory Committee, increased use of patient reported outcomes in clinical studies, patient preference  patient preference studies in decision making
  • Promote Culture of Quality and Organizational Excellence CDRH staff formal quality training and certifications, PMA Critical-to-Quality Pilot Program to streamline the pre-market approval process

Foster innovation to spur the development of safer, more effective technologies, assure timely patient access

  • Annual number of approved devices has steadily

Three strategic priorities for 2018-2020: Holistic approaches to improvement

  • Employee Engagement, Opportunity, and Success. Recognize connection between taking care of FDA employees and achieving FDA vision
  • Simplicity. Streamline policies, processes, programs, approaches e.g. Total Product Life Cycle approach to integrates our pre-market, post-market surveillance, Least Burdensome principle
  • Collaborative Communities. Foster public and private sector Collaborative Communities,  advancement of smart regulation and rise of ‘Patient Scientists’

2016-2017 Accomplishments

2018-2020 Strategic Priorities

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Capture.JPGNew steps to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs 

Enhance transparency around FDA drug approval decisions by better informing of  clinical study reports (CSRs) to scientists, providers, and patients

  • Current approach- Summaries in [email protected] database
  • New pilot program –  Post portions of clinical trial-related summaries from the pivotal trials that were submitted to the FDA by drug’s sponsor on [email protected]
  • Include study report body, protocol and amendments, and statistical analysis plan for pivotal studies
  • New website

Add  ClinicalTrials.gov identifier number (NCT #) to FDA summaries

  • Easier to associate clinical trial listings on ClinicalTrials.gov to FDA communications about specific drugs, including product labeling and advisory committee meeting materials


Image result for DoD logoFDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel

Joint program with Health Affairs to prioritize efficient development of safe and effective medical products intended to save lives of American military personnel

  • Better understand military’s medical needs for deployed personnel
  • Give highest level of attention to and expedite its review of priority DoD medical products
  • Provide ongoing technical advice for rapid development and manufacturing
  • Take closer look at products currently under development to determine opportunities to expedite availability

FDA and Health Affairs to hold workshops to discuss scientific and clinical development


Capture.JPGInternal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by CDRH

Implement regulations regarding internal agency supervisory review of certain CDRH decisions related to conform to FDASIA and the Cures Act

  • Provide transparency for internal and external stakeholders on supervisory review of decisions
  • Give requesters new predictability through binding deadlines on “significant decisions”
  • Codify types of decisions that are considered “significant decisions”

Following decisions being proposed as significant decisions – “517A decisions”

  • 510(k): Not substantially equivalent; Substantially equivalent
  • PMA/HDE: Not approvable; Approvable; Approval; Denial
  • Breakthrough Devices: Expedited access pathway, Grant, Denial
  • IDE: Disapproval, Approval
  • Failure to reach agreement on protocol
  • “Clinical Hold” determinations


Capture.JPGStatement from FDA Commissioner Scott Gottlieb, M.D. responding to GAO report and updating FDA’s ongoing efforts to increase access to complex generic drugs

U.S. Government Accountability Office (GAO) published report titled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.

  • GAO studied issues related to FDA’s review and approval of “nonbiological complex drugs”
  • Recommendation for FDA — announce plans to issue or revise related guidances

FDA Actions

  • Drug Competition Action Plan: Promoting competition and access, to generics
  • Focus GDUFA resources to aid generic drug developers of complex products
  • Issued four general guidance documents covering complex generics

Looking forward

  • Develop additional guidance for clarifying “sameness” requirements for ANDAs
  • Specific guidance on drug-device combination products


Capture.JPGNew policy steps for strengthening public warning and notification of recalls

FDA to improve recall processes to help ensure product safety

  • Recalls remove potentially unsafe products quickly and efficiently
  • Draft guidance describes public warning and notification of recalled products
  • Gives industry clear direction on communication of recalls and empower consumers by providing timely and accurate information

FDA Enforcement Report

  •  Listing of all recalls monitored by  FDA. You can read more about the changes the FDA made to its Enforcement Report in today’s blog


Capture.JPG2018 Compounding Policy Priorities Plan

2018 Compounding Policy Priorities Plan to implement federal compounding laws and advance public health mission

  • In accordance with Drug Quality and Security Act (DQSA)
  • Recognizes  importance of compounders’ role in access to quality drugs
  • Tailor policies for traditional compounding pharmacies and outsourcing facilities

2018 Priorities

  • Risk-Based Approach to Manufacturing Standards for Outsourcing Facilities
  • Restricting Compounding of Drugs that are Essentially Copies of FDA-Approved Drugs
  • Regulating Compounding from Bulk Drug Substances
  • Solidifying FDA’s Partnership with State Regulatory Authorities
  • Finalization of Biological Products Guidance and Clarifying Other Policies on Activities that Compounders Undertake
  • Compliance


Capture.JPGLocally-Acting Orally Inhaled and Nasal Drug Products 


Demonstration of Bioequivalence (BE) for locally-acting orally inhaled and nasal drug products  presents a unique challenge

  • FDA guidance to measure bioavailability under NDA and BE under ANDA
  • Increased understanding of complex interactions between formulation, manufacturing, and device

Better characterization, tools/methods to investigate  BE and product specific outcomes

  • Orally Inhaled Drug Products
  • Locally Acting Nasal Products


Image credits: FDA, DoD


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