It remains uncertain whether a legal review by the European Commission that since June has delayed public consultation of draft ICH Q12 post-approval changes guideline can be resolved during this week's ICH meeting in Geneva.
At its meeting in Geneva, Switzerland, this week, the International Council for Harmonization will try to overcome concerns the European Commission raised in an 11th-hour legal review of the Q12 guideline on post-approval changes that ICH has been developing for the past three years.
At the previous ICH meeting, held the week of May 29 in Montreal, Canada, the council's management committee and assembly...
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
