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
Increasing volume of imports: six million (2002) – 35 million (2015)
FDA reviews imported products to determine admissibility.
- Submit import entries through Automated Commercial Environment (ACE). A final rule published on November 29 in the Federal Register
- ACE piloted by U.S. Customs and Border Protection (CBP)
- ACE include technical revisions for streamlining
- FDA will provide assistance to filers
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
- Responses to treatment differ – may need to try several treatments
- In crisis situation – call National Suicide Prevention Lifeline
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
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