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Category Archives: FDA

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21st Century Cures Act Passes House: Could Usher In Broad Reforms to Drug Approval Process

Posted in FDA, Guest Contributor, Legislation, Prescription Drugs and Medical Devices
On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures Act” (the “Act”) would foster significant regulatory changes in the introduction of new drugs to the market. The… Continue Reading

News from the Health Law Gurus™: Week of April 20th, 2014

Posted in Compliance Issues, FDA, HIPAA, Medicare, News from the Health Law Gurus, Privacy, Regulations
News from the Health Law Gurus™ is a weekly summary of notable health law news from around the country with helpful links to related content. Check back every Friday for the latest health law news stories. Passwords Affected from Heartbleed – HealthCare.gov, the website for the federally-facilitated health insurance exchanges under the Affordable Care Act,… Continue Reading

Where There’s Smoke, There’s Proposed Regulation: FDA Seeks to Bring E-Cigarettes Within Its Regulatory Authority

Posted in FDA, Regulations
On April 24, 2014, the Food and Drug Administration (“FDA”) released a proposed rule (the “Proposed Rule”) that will expand its authority to regulate items like electronic cigarettes (“e-cigarettes”). The Proposed Rule essentially makes currently unregulated tobacco products subject to FDA regulation under the Federal Food, Drug and Cosmetic Act. In other words, the FDA… Continue Reading