A Little Rock, Arkansas, outsourcing pharmacy continued to defy FDA even after the agency went to court for an injunction to shut down the pharmacy's drug compounding operations over continued lack of sterility. Cantrell Drug Co. could have accepted proposed consent decree terms but instead countered in federal bankruptcy court with an injunction request of its own.
An outsourcing pharmacy in Little Rock, Arkansas, has responded to a request by FDA and the Justice Department for a federal district court to issue a preliminary injunction against its manufacture and distribution of adulterated drugs with an injunction request of its own.
Rather than avoid the injunction by agreeing to proposed terms for a consent decree, Cantrell Drug Co. has asked a...
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.
