Ixodes has an approved clinical protocol with the FDA as well as the clinical design with the German BfArM
In its resolution the Council of Ministers indicated that they deeply regretted that the German BfArM
and many other health authorities of EU member states had banned or restricted the sale of kava-containing products on the basis of a very questionable evaluation of scientific data, against the recommendation of many scientific experts.
After the occurrence of a few cases of severe hepatotoxicity, claimed to be possibly be related to the intake of kava products, the German BfArM
re-evaluated the benefit / risk ratio of kava and banned kava preparations up to a homoeopathic dilution of D4.
Finally, the BfArM
in Germany was the first authority to ban kava on June 14, 2002.
The International Society for Aesthetic Plastic Surgery (ISAPS) has been officially informed by the German authorities at the BfArM
Institute that the former company, GfE Medizintechnik GmbHin Germany, sold implants that were manufactured using PIP components.
Trial Application (CTA) for Atu027 being submitted to the BfArM
, the German
Atu027 and, in particular, consideration of recent discussions with BfArM
will outline the EU guideline on the validation of bioanalytical methods.
HM Hung and SJ Wang, both from the US FDA and A Koch, from Germany's BfArM
, provided regulatory insights into the use of adaptive designs by reviewing the FDA's Draft Guidance for Adaptive Designs and the Reflection Paper on adaptive designs recently developed by the European Medicines Agency (EMEA).
Strater are representatives of Bayer Healthcare AG and the LORENZ Life Sciences Group, as well as representatives from the following health authorities: Germany's BfArM
, Canada's Health Canada, and Austria's AGES.
She is working with BfArM
on the latest eMEDDEV requirements emerging in the EU.
and ANSM also confirmed, in minutes of each of their respective scientific advisory meetings, that if successful, this Phase IIb trial may serve as a basis for Phase III pivotal trials of aramchol.