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  • New China FDA Document Clarifies Device Crackdown Plan

    On 15 March 2014, the China Food and Drug Administration (CFDA) issued a question and answer document designed to clarify the purpose of an earlier 13 March 2014 notice on the new national Special Action Program (SAP). That notice, sent to Chinese provinces and municipalities, called on local authorities to crack down on illegal activities relating to medical devices, and especially medical device registration, production, distribution and use.  The Program wi...
  • Do Indian Companies Have a Chronic Data Falsification Problem? FDA Warning Letters Indicate 'Yes'

    Indian generic pharmaceutical manufacturer Ranbaxy may be just the latest company to see its products banned from entry into the US, but it's also the latest company to join far more dubious company: the list of Indian manufacturers accused of fabricating and falsifying data in an attempt to fool US regulators. Background Regulatory Focus covered the start of FDA's crackdown on Indian companies in 2013, when we noted that regulators had sent a series of seriously-word...
  • FDA in Crackdown Against Diabetes Companies for Marketing Unapproved Drugs

    The US Food and Drug Administration (FDA) seems to be on a major kick against unapproved and misbranded diabetes drug products, according to the most recent batch of Warning Letters released on 23 July 2013. Start of a Crackdown FDA often uses batches of Warning Letters to make an enforcement point against practices it does not favor. Rather than releasing 10 Warning Letters over 10 weeks, it may concentrate them all into a single week in the hopes of making a statement...
  • In Midst of Crackdown, New Batch of FDA, FTC Warning Letters Target Unapproved Flu Products

    The US Food and Drug Administration (FDA) has released a bevy of new warning letters all aimed at "unapproved flu products," part of a recent crackdown by the agency on products it deems to be either ineffective or potentially dangerous. Background The 2012/2013 flu season has been a particularly strong one in the US, and high public demand for flu vaccinations has put FDA on edge, and for good reason: The combination of drug shortages and public concern is a potent rec...
  • US Regulators Crack Down on Supplement Manufacturers

    The US Food and Drug Administration (FDA) has moved against three dietary supplement manufacturers for allegedly marketing their products using claims that would cause them to be drugs under the Federal Food, Drug and Cosmetic Act , as well as quality deficiencies. The three announcements came between 23 and 25 October-an unusually high rate of enforcement activity against a particular sector. The first action , taken against New York-based Confidence, Inc., related t...