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The FDA Feb. 1 began sending status updates to all drugmakers with pending ANDAs to allow them to better estimate when their products can launch. Read More
Government auditors Monday criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
A new data standard being proposed by the Clinical Data Interchange Standard Consortium could give sponsors and FDA reviewers greater flexibility to analyze data, if adopted by the agency for drug review applications. Read More
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve. Read More
Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. Read More
Shire said Thursday it will abandon the development of its blockbuster hyperactivity drug Vyvanse as a treatment for major depressive disorder after two failed Phase III trials. Read More
To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file. Read More
Sponsors of new drugs and biologics intended to treat chronic pain should plan on submitting more safety data than they would to support candidates for acute pain, the FDA says. Read More
As the FDA moves to update and standardize data submission standards for NDAs, ANDAs, INDs and BLAs, it’s warning sponsors they will only have two years to come into compliance once guidance is finalized later this year. Read More
Following the FDA’s lead, the Scottish Medicines Consortium (SMC) said Monday it plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More