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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Strengthens Supervision of Online Drug and Medical Device Sales The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal a...
  • Regulatory NewsRegulatory News

    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
  • Group Sues FDA, Seeking 'Confidential Information' About Antibiotic Prescribing Data

    • 06 December 2012
    A consumer advocacy group has filed a lawsuit against the US Food and Drug Administration (FDA) for withholding data regarding the use and sale of antibiotics used in food-producing animals, saying the denial of its Freedom of Information Act (FOIA) request for the information was "unlawful." The group, the Government Accountability Project (GAP), which bills itself as a whistleblower protection organization, said it objects to FDA withholding certain data reported to ...
  • In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

    • 04 December 2012
    In a potentially landmark ruling, the US 2 nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech. Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US. Currently, companies are not a...
  • Indian Drug Representatives Strike for Strengthened Regulations

    More than 150,000 sales representatives for pharmaceutical companies went on strike on 23 August in the hopes of spurring greater regulation of their industry in an attempt to reduce corruption and bolster integrity, according to the union that represents the workers. The sales reps are a part of the Federation of Medical Representatives Association of India ( FMRAI ), reports the India News Network , and they campaigned throughout the day to draw attention to the probl...
  • FDA Wants More Data on Antibiotics

    The US Food and Drug Administration (FDA) has released an advanced notice of proposed rulemaking-the precursor process for promulgating a regulation-saying it wants to reassess the information collected from industry regarding  veterinary antimicrobial drug sales, distribution and resistance data. In an advanced Federal Register posting , FDA said it is considering the changes through  statutory authority given to it under section 105 of the Animal Drug U...
  • Untitled Letter Cites BMS for Alleged Misbranding

    • 18 July 2012
    Pharmaceutical manufacturer Britsol-Myers Squibb was the recipient of an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) regarding marketing materials for its drug Ixempra (icabepilone). In the Untitled Letter , FDA calls a sales aid for Ixempra , submitted to the agency for review by BMS, as misleading due to "unsubstantiated efficacy claims" and an implied indication broader than the one approved by the ag...
  • J&J Announces Planned Cessation of Vaginal Mesh Sales

    Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding. Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment op...