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Leaders of the House Energy & Commerce Committee sent letters on Thursday to the FDA and five other agencies asking for a briefing on the fentanyl crisis. Read More
The FDA has asked Merck to team up with IBM, KPMG and Walmart to put together a new pilot program testing whether blockchain can help regulators track and trace prescription drugs along the increasingly complex supply chain. Read More
The FDA needs more data on the likely impact on patients before it introduces tighter controls on high-strength opioids and doses for outpatient settings, the agency heard in a two-day public meeting. Read More
A Florida drug company at the heart of ongoing disputes over the price of life-saving drugs has doubled down, bringing a federal lawsuit against the FDA for the agency’s alleged end-run around the drug company’s commercial rights. Read More
The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side of the law. Read More