US FDA hopes to expedite NDA and ANDA reviews and lay groundwork for eventual ICH adoption by asking sponsors to make better use of CTD's Quality Overall Summary, which could allow agency reviewers to focus on patient impact and other key factors.
The US FDA has invited pharmaceutical companies to explore new ways of using quality overall summaries to strengthen and expedite chemistry, manufacturing and control reviews of new and generic drugs.
What FDA and industry learn could help the International Conference on Harmonization as it considers updating the quality overall summary,...
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.
