US FDA's Brexit: One Staffer Moving, But Impact Still May Loom Large
Uncertainty about Brexit's impact on the FDA-EMA mutual recognition agreement are among issues worrying regulators as countdown continues to the UK's departure from the EU.
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Exit Interview: US FDA’s Sandra Kweder Reflects On A 30-Year Career As She Heads Into Retirement
Having recently returned from six years overseas as the FDA’s liaison to the European Medicines Agency, ‘now was a good time to try something different,’ Kweder says in a Pink Sheet interview. Her tenure at the agency included numerous leadership roles in CDER as well as spearheading the development of the pregnancy labeling rule.
US FDA Would Get Mandatory Recall Authority For Drugs Under House Funding Bill
The change would let FDA forcibly pull prescription and over-the-counter drugs off the market just like vaccines, medical devices and other products.
China Unlikely To Be Included In US FDA's Project Orbis In The Near Term
Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.