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As drug price increases continue to make waves on the national level, Congress is taking the matter into its own hands by requiring generic drugmakers under the Medicaid Drug Rebate Program to pay higher rebates if generic prices rise too quickly.
Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled new guidance on the eligibility requirements for medical device and in vitro diagnostic (IVD) companies looking to reduce assessment fees by as much as 70%.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
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The US Food and Drug Administration (FDA) is now encouraging employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. View More
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter. View More
Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. View More
Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy’s in India, according to the US Food and Drug Administration (FDA). View More