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  • Will CDRH Soon be Reviewing Video Games?

    • 07 August 2012
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    Video games aren't traditionally known as medical devices. In fact, there aren't yet any approved by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), the US's medical device regulatory body. But all that could soon be changing. At least one company, Boston and San Francisco-based Akili Interactive Labs , is on the verge of taking a video game it has specifically tailored for the treatment of attention deficit/hyperactivity d...
  • DEA to Increase Supply of ADHD, Opioid Ingredients in Light of Shortages

    • 06 July 2012
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    The US agency in charge of setting drug production quotas for substances regulated under the Controlled Substances Act (CSA) is proposing a mid-year adjustment in its production quotas for the active pharmaceutical ingredients contained within many attention deficit hyperactive disorder (ADHD) drugs and painkillers in response to growing drug shortages. In a 5 July 2012 Federal Register posting, the US Drug Enforcement Administration (DEA) announced it is looking to ...
  • MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

    Some medicines approved to treat attention deficit hyperactivity disorder (ADHD) in the UK will soon include information in the patient information leaflet specifically targeted towards those under the age of 18 thanks to a partnership between regulators, academia and industry. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday, 7 June it is moving to implement the new information layout-reportedly the first time it has been done in th...
  • Consumers Warned of Fake Adderall in US

    The US Food and Drug Administration (FDA) warned consumers on 29 May of counterfeit copies of Teva Pharmaceutical Industries' attention deficit hyperactive disorder (ADHD) drug Adderall, saying some consumers had obtained copies of the drug containing the incorrect active pharmaceutical ingredients (APIs) through an online pharmacy. ADHD drugs like Adderall use a combination of APIs known as amphetamine salts. In the case of Adderall, the drug contains dextroamphetamine ...
  • ADHD Drugs Remain in Short Supply

    A shortage of a medication used to treat attention deficit hyperactive disorder (ADHD) shows little sign of abating as the US Drug Enforcement Administration (DEA) continues to regulate the amphetamine salts that act as the drug's active pharmaceutical ingredient (API). The DEA controls the supply of the amphetamine salts via a manufacturing quota system, and authorizes certain amounts of the amphetamine salts to be distributed based on what the agency determines to be t...