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Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace...


Report of the French Court of Auditors on budget multiannuality
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Pierre Moscovici, First President of the French Court of Auditors (“Cour des comptes,” the highest public finances authority in France), recently testified before the Senate...


FDA expands mutual reliance and harmonization with foreign regulators for inspectional oversight

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an...


Biden Administration supports waiver of WTO IP rights for COVID-19: Next steps for innovators

On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO)...


Time’s up: New enforcement era for regenerative medicines begins June 1

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative...


Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the reintroduced Republican-led H.R. 19, the “Lower...


Insurance regulatory news, 1 April 2021

This week, reports on recent UK and EU regulatory developments of interest to insurers and their intermediaries. See also our Financial institutions general regulatory news in the Related...


First steps towards taking into account the organizational impacts of health care technologies

On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products...


Safeguarding drug development at academic institutions

Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. Innovative therapies are moving from university...

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