Sep 14 FDA considers ban on electric shock devices used to curb self-harm By Lauran Neergaard, Associated Press Self-injury is one of the most difficult behaviors associated with autism and other developmental or intellectual disabilities, and a private facility outside Boston that takes on some of the hardest-to-treat cases is embroiled in a major debate: Should it use… Continue reading
Aug 05 New FDA ‘gluten-free’ regulation rolls out By Anna Christiansen Starting this week, all food products marked as “gluten-free” can only make the claim if they contain less than 20 parts per million of gluten. Continue reading
Jul 26 FDA will consider approval of biosimilar drug for first time By Hannah Yi Americans are a small step closer to accessing less-expensive specialty drugs known as biologics. The Food and Drug Administration for the first time accepted an application for the approval of a copycat “generic” version of the brand name drug Neupogen,… Continue reading
Jul 24 Are drug companies using safety rules to block generic competition? By Megan Thompson A new study claims pharmaceutical companies may be misusing FDA safety guidelines to block generic drugs from market, costing the health care system more than $5 billion dollars a year. Continue reading
Jul 07 FDA regulation can’t keep pace with new mobile health apps By Joshua Barajas Although lawmakers have repeatedly called on Congress to create a special office within the FDA to regulate health apps available in the mobile marketplace, the idea was rejected at a roundtable discussion on medical device security in… Continue reading
Jun 22 Lawmakers concerned chocolate e-cigarettes may lure teens By Vic Pasquantonio As of January of this year, there were more than 460 e-cigarette brands available for purchase online, and around 7,700 flavors, including Swedish fish, roasted marshmallow and vanilla cupcake. Continue reading
Jun 21 Proposed laws on experimental drugs stir debate By Stephen Fee This May, Colorado's governor signed the nation's first "right to try" bill, which allows terminally ill patients to try unapproved — and potentially dangerous — drugs outside of clinical trials and without approval from federal regulators. Continue reading
Jun 21 Missouri measure would enact drug program for dying patients By Mike Sherry, The Hale Center for Journalism If you were dying and had exhausted all conventional treatment options, wouldn’t you want immediate access to a drug that might prove to be a miracle cure? That’s the promise of proposed legislation that could make Missouri the third state… Continue reading
May 19 Colorado first state to pass ‘Right to Try,’ or the ‘Dallas Buyers’ Club’ law By Patti Parson Terminally ill patients often are frustrated to hear about experimental drugs they think might help them, but have not yet been approved by the Food and Drug Administration -- a process that often takes years. Continue reading
May 17 Debate over genetically modified foods continues amid confusion By Mary Clare Jalonick, Associated Press Vermont recently became the first state to require labeling of genetically modified organisms (GMOs). Bills and ballot initiatives are pending in many more. What about the rest of the country? And does labeling matter?… Continue reading