The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing obligations with respect to 347 medicinal products...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more
On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more
In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more
International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more
18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more
Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more
The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s...more