EU inspectorates are putting off their plans to undertake any good manufacturing practice inspections in the US wherever possible, in anticipation of the EU-US mutual agreement coming into force in November.
The European Medicines Agency says it will make efforts to defer any good manufacturing practice inspections in the US in anticipation of the EU-US mutual recognition agreement coming into operation from Nov. 1 onwards. The agreement, when operational, will allow drug regulators in the two regions to rely on each other’s GMP inspections conducted within their respective territories.
The EMA told the Pink Sheet that the “EU inspectorates will be making maximum use of existing EU procedures to...
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.
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.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
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.
Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.
