Julie Dohm, who led a wide range of initiatives to bolster FDA's oversight of compounding pharmacies, will be joining Covington & Burling after leaving the agency March 29. A replacement has not yet been announced.
Julie Dohm, the senior science advisor for compounding who serves as the US FDA lead on compounding and has helped to spearhead a wide range of initiatives to enforce the Drug Quality and Security Act (DQSA,) will be leaving the agency on March 29. She has been credited with her steady leadership in guiding the agency's compounding office through a difficult time.
Dohm will be joining the law firm of Covington & Burling. A replacement at FDA has not yet been announced.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
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.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
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.
