Blogs

Focus On Regulation

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA). HTA is a multidisciplinary process or tool...

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The FDA now offers cGMP Declarations

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. The online application makes it...

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VA and SBA Release Complementary Final Rules Updating their Veteran-Owned Small Business Regulations

On September 24, 2018 and September 28, 2018, the Department of Veterans Affairs (VA) and the Small Business Administration (SBA), respectively, released complementary final rules (VA final ...

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UK MHRA consults on no-deal Brexit legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...

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For Now, DoD Halts Efforts to Change Policy on Progress Payments

Deputy Secretary of Defense Patrick Shanahan announced on Monday, October 1, 2018, that the U.S. Department of Defense (“Department” or “DoD”) was withdrawing its...

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