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FDA Senior Official’s Top 10 Changes for CDER in 2015

March 12, 2015 | Mark A. Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

cedResearch Triangle Park’s Council for Entrepreneurial Development (CED), in collaboration with the NC Biotechnology Center and the NC Biosciences Organization (NCBIO), held its annual Life Sciences Conference last week with the theme of #TheNext10.

The Triangle’s premier entrepreneurial event, which brings together life science pioneers, visionaries, and investors to network and share strategies and experiences, was held at the Raleigh Convention Center, March 3-4.

Speakers and panels at the meeting focused on what the biotechnology industry will be facing in the next 10 years, including funding innovations, venture philanthropy, personalized medicine, and other industry trends.

The Changing Face of CDER
On the second day of the meeting, Richard Moscicki, MD, FDA’s Deputy Director for Science Operations in the Center for Drug Evaluation and Research (CDER) provided his thoughts on “The Changing Face of Drug Evaluation and Research.”

Playing off the theme of the meeting, Dr. Moscicki provided a “Top Ten” list of the most important changes being made at CDER.

CDER’s Most Significant Change
Dr. Moscicki identified the creation the new Office of Pharmaceutical Quality (OPQ) as the single biggest change for CDER moving into 2015.

Underscoring the importance that CDER is putting on this initiative, Janet Woodcock, the current Director of CDER, has assumed the role of Acting Director of this new office until it gets off the ground and is running smoothly.

OPQ centralizes all aspects of the quality review process for new drugs and generics under one roof, and was born out of the realization that the established approach to quality assessment was actually inhibiting innovation.

The emphasis going forward will be truly of quality and not just compliance.

tenThe Rest of the Top Ten

  • GDUFA (Generic Drug User Fee Act)
    FDA is working hard on implementing the new performance goals in the generic drug user fee act – 10 month reviews are coming into play beginning this year – and getting through the backlog of pending ANDAs (which still number in the thousands)!
  • BPCIA (Biologics Price Competition and Innovation Act)
    CDER is handling 52 biosimilar programs for 15 different reference products. Four companies have publicly disclosed their BLA submissions, and one advisory committee meeting has been held for a biosimilar product.

    How to handle non-proprietary naming is still being worked out.

  • Sentinel
    This program aims to transform the way FDA-regulated products are monitored, with rapid (near real-time) responses to emerging product safety issues.
  • Patient-focused Drug Development
    CDER is moving towards incorporating more of the patients’ voice into their thought processes and review decisions.

    “Patients are the experts with regards to quality of life issues and the balance between efficacy and acceptable levels of safety.”
  • Antibacterial Drug Development
    The FDA is actively implementing the GAIN Act provisions (Generating Antibiotic Incentives Now). Over 30 products have been designated and there have been 6 product approvals thus far.
  • Progress in Rare Diseases
    Orphan drug products are making high use of expedited approval pathways. Seventeen (17) of the new product approvals in 2014 (41%) had orphan drug designations.
  • Breakthrough Designation
    Very popular! FDA is taking an “all hands on deck” approach to the evaluation of these products. There have been over 200 designation requests and over 60 have been granted.

    Fourteen (14) of last year’s new product approvals (22%) carried this new designation.

  • Advertising and Promotion
    FDA is re-examining their approach to promotional labeling in light of recent case law regarding first amendment rights.
  • 21st Century Cures Act
    This landmark legislative initiative, spearheaded by representatives Upton (R-MI) and DeGette (D-CO), aims to ensure that our laws and regulatory framework keep pace with medical innovation so that new cures get to patients as quickly as possible.


Category: Regulatory Affairs
Keywords: CED, Life Sciences Conference, CDER, Moscicki, OPG

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