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As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.”
Negotiating a clinical trial agreement (CTA) can be a maze of confusion, filled with difficult-to-understand legalese and contractual traps seemingly around every corner. An accidental omission, an unintended commitment, or even just the wrong choice of words can lead to misunderstandings and an agreement that fails to do what you want it to.
UK regulators have backed away from a proposed post-Brexit requirement that drug sponsors have a point of contact in the UK to conduct clinical trials.
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