Warning letter details extensive GMP and data integrity remediation expectations for Matoda plant and calls for the privately held generic drug manufacturer to immediately confront its corporate quality issues globally.
A 28 July warning letter from the US Food and Drug Administration called on Intas Pharmaceuticals Ltd. to conduct a global quality assessment now that a litany of data integrity failures agency investigators observed at one of its facilities near Ahmedabad, India, show that its corporate quality system is ineffective.
The warning letter, which lays out a sweeping remediation plan for the plant, located southwest of Ahmedabad near Matoda Village,...
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
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.
