On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina...more
A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more
At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more
With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more
The Belgian Federal Agency for Medicines and Health Products (AFMPS) has announced that it has abolished measures introducing quotas for the supply of paracetamol-based medicinal products. ...more
The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. ...more
While several drugs are being studied in Japan to treat COVID-19, none have yet been approved. However, reports indicate remdesivir, a drug developed by as a treatment for Ebola virus disease, has been administered as a...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
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...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
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
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
Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence....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
On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more