Focus On Regulation

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological ...

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“New Deal for Consumers” – draft package adopted by the European Commission

The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market.

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UK 'Sugar Tax' comes into force – new guidance published for industry

The UK tax authority HM Revenue and Customs (HMRC) has published a series of practical guidance documents and additional online information to assist companies with understanding and...

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UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations

The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and...

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D.C. Circuit calls 2015 FCC TCPA autodialer decision “utterly unreasonable”; Strikes down reassigned numbers framework

The United States Court of Appeals for the District of Columbia Circuit issued its long-awaited decision in ACA International, et al, v. FCC, a case involving multiple petitions for review...

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