The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.
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Digital Health: Where is the Action for Entrepreneurs?
Doctors prescribe medicine to help keep us healthy. However, a mistake that leads to the wrong medicine being taken can cause serious injury or death. Unfortunately, these types of errors are not uncommon....more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more
In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more
In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups Scheduled....more
The number of mobile applications (apps) available to consumers on their iPhones, Androids, and iPads is astonishing. As of January 2013, there were more than 775,000 different apps available to iPhone and iPad users. It...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more
In This Issue: Leading the News; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more
In This Issue: Leading the News – Budgets and the Continuing Resolution (CR); Implementation of the Affordable Care Act; Other Congressional and State Initiatives; Other HHS and Federal Regulatory Initiatives; Other...more
In This Issue: - General Legislative - Agriculture and Food - Budget, Appropriations and Sequestration - Cybersecurity - Defense - Education - Energy - Environment - Financial Services -...more
As CES 2013 draws to a close, Michael Esquivel, a partner in Fenwick’s Start-ups and Venture Capital Group, identifies where the action is for entrepreneurs and investors in digital health and healthcare IT. According to...more
Originally published in mHealth Newsletter on November 14, 2012. One might not associate the Federal Communications Commission (FCC) with mHealth issues. Yet, the FCC has a vital role to play in this field, and if...more
The Food and Drug Administration (FDA) recently published the names of healthcare providers that received contaminated products from New England Compounding Center’s facility in Framingham, Massachusetts. The FDA has...more
In a move he says will improve the quality of health care and cut health system costs, FCC Chairman Julius Genachowski announced the Commission will work toward implementing recommendations proposed by the mHealth Task Force,...more
Venture investment in healthcare convergence technologies soared in the first half of 2012. According to a recent report from Burrill & Co, digital health, into which they group healthcare IT, mobile health and wireless...more
Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more
As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more
You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more
Furthering the use of commercial wireless networks to deliver health information, the Obama Administration recently announced its new Text4baby campaign, which sends free regular text messages with health information to...more
The Federal Communications Commission (FCC) recently granted a rule waiver requested by Boston Scientific Corporation (Boston Scientific), allowing it to continue to manufacture and market its Contak Renewal TR product line...more
Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new “mHealth” (mobile...more
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