FDA News: Trade Alert, Bipolar Disorder, Pathogens, Combination Products – Drug and Device Digest

FDA BRIEF: Week of November 28, 2016


Trade Alert: FDA Issues New Import Data Requirements

By: Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy

Howard SklambergIncreasing volume of imports: six million (2002) – 35 million (2015)

FDA reviews imported products to determine admissibility.

To facilitate:


Bipolar Disorder and FDA-Approved Treatments



  • Bipolar I disorder (also known as manic-depressive illness): Unusual shifts in mood, energy, activity levels,manic episodes .
  • Bipolar II disorder: less severe manic episodes, can switch to major depressive episodes.

FDA Approved Bipolar Drug Treatments (Division of Psychiatry Products)

  • mood stabilizers: balance brain chemicals to prevent mania, hypomania, or depressive episodes
  • antipsychotic drugs: new atypical antipsychotics- safer that older antipsychotic drugs

Bottom Line


How Pathogens cause DiseaseCDERConversations 715pxPhoto of Daniela I. Verhelyi, Office of Biotechnology Products, Studying How Pathogens Cause Disease

Daniela Verthelyi, Chief, Laboratory of Immunology, Office of Biotechnology Products, Office of Pharmaceutical Quality, CDER

Scientists in CDER and CBER advancing regulatory science and research on pathogens

Examples of important discoveries from CDER’s research

  • Dr. David Frucht : Mouse models with the anthrax infection
  •  Dr. Kathleen Clouse : Study Ebola virus by using non-infectious components
  • Dr. Daniela Verthely: New model of infection with Zika virus
  • Other : Bacillus anthracis, Epstein-Barr virus,  HIV, Sindbis and Tacaribe viruses, Ebola, Junin, and Machupo viruses, vesicular stomatitis virus

Address public health issues in the US and abroad.


Combination Products Review Program: Progress and Potential


Nina L. Hunter, Ph.D., Associate Director for Science Policy,

Robert M. Califf, M.D., Commissioner 

Nina HunterRobert Califf

Combination products account for a growing proportion of products for FDA review

FDA addressing issues identified in Intercenter Consult Process Study Report

Great progress over the past year summarized below

Combination Products Review Table



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