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An analysis of the impact of FDA’s four expedited programs on
development and review of drugs for serious conditions over the last two-and-a-half
years since breakthrough therapy designation was introduced, including a
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.
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Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week. View More
Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as "Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. View More
New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. View More
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. View More