The Maryland General Assembly is considering two bills that would require pharmaceutical companies to notify the state ahead of drug price increases. Source: Drug Industry Daily
India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that…
The EMA identified ways to address the drawbacks of using electronic healthcare records and real-world evidence to support drug development and regulatory decision-making. Source: Drug Industry Daily
International guidance on pediatric drug development should include provisions for remote electronic consent, and should clarify the information provided to patients prior to their enrollment in clinical trials, according to…
Pick and Pay, also doing business as Cili Minerals, was ordered to cease operations by a federal district judge until it gets written permission from the FDA to resume. Source:…
The head of the brand-name pharmaceutical industry’s trade group called for streamlining of the generics approval process, and a greater shift to value-based payments. Source: Drug Industry Daily
Companies want a choice between providing quality metric reports on either a product-by-product or a site-by-site basis. Source: Drug Industry Daily
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Source: Drug Industry Daily
The FDA delivered a warning letter to Humco for deviating from GMP standards and manufacturing unapproved and misbranded drugs. Source: Drug Industry Daily
The Biosimilars Council is arguing that the federal law governing biosimilars does not grant branded biologics an extra six months of exclusivity. Source: Drug Industry Daily