• Regulatory NewsRegulatory News

    Legislators Call for FDA to Further Restrict Use of Phthalates in Medicines, Citing Risks

    In December 2012, the US Food and Drug Administration's (FDA) drug regulatory body, the Center for Drug Evaluation and Research (CDER), indicated that it wanted to limit the use of some phthalates as excipients in medicines. Now two legislators have a message for the agency: There's more that needs to be done. Background FDA's December 2012 guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products , explained that the agency had foun...
  • Regulatory NewsRegulatory News

    FDA Recommends Against Use of Painkillers for Teething Pain

    US Food and Drug Administration (FDA) regulators are warning that young children who are teething and experiencing pain should not be given lidocaine, a topical painkiller, due to the serious and even fatal risks associated with the drug. In a 26 June announcement , FDA said that the application of oral viscous lidocaine 2% solution had been associated with at least 22 reports of serious adverse reactions, "including deaths," in young children and infants. At leas...
  • Report: Regulatory Framework for Supplements Lacking Necessary Safeguards

    • 07 August 2012
    Be careful of vitamins and supplements, warns a new report out from consumer product watchdog Consumer Reports (CR). In its 3 August 2012 piece, 10 Surprising Dangers of Vitamins and Supplements , CR explains consumers shouldn't assume so-called "all natural" supplements, vitamins or herbal supplements are safe or effective. "They may be neither," CR remarked. Adverse event signals-not necessarily signs of causation, but cause for further investigation-poured into ...
  • Device Safety Reassessed

    • 09 April 2012
    The Korean Food and Drug Administration (KFDA) held a briefing focused on the reassessment of the safety of devices based on 12 years marketing experience and consumer reports. The briefing on 6 April covered devices such as radiation treatment devices, sutures, diagnostic devices, bio-monitoring equipment, treatment equipment and cardiovascular equipment. Read more: '12 briefing held medical device notification More Breaking News from RegLink
  • Full Information From FDA OTC Switch Meeting Released

    The complete information from the 23 March over-the-counter switch meeting between the US Food and Drug Administration (FDA) and industry and public stakeholders has been made public. FDA is currently considering whether to create regulations that would make it easier for consumers to buy medications that are currently prescription-only. The so-called "over-the-counter (OTC) switch" would make some popular medications available OTC if they can be used safely with minimal...
  • FDA Plans Study on Corrective DTC Advertising

    The US Food and Drug Administration (FDA) is calling for a study on corrective direct-to-consumer (DTC) advertising and its impact on correcting misperceptions about a product's safety and efficacy for a given indication. "FDA regulations require prescription drug advertisements to contain accurate information about the benefits and risks of the drug advertised.  When this is not the case, corrective advertising is designed to dissipate or correct erroneous belief...
  • Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

    Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products. The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market ...