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  • Regulatory NewsRegulatory News

    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Quality Control of Medical Devices China Food and Drug Administration (CFDA) has posted guidance on quality control and finished product release for medical devices. The document details the procurement control procedures, finished product inspection rules and other processes CFDA wants companies to establish to ensure medical devices meet manda...
  • Regulatory NewsRegulatory News

    FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo

    The US Food and Drug Administration (FDA) has agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications of renal cell carcinoma, metastatic melanoma and non-small cell lung cancer.  The modification of the “Dosage and Administration” section of the label replaces “the single dose regimen of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every t...
  • Regulatory NewsRegulatory News

    B-MS Pays $14M to Settle SEC Charges over Bribing Health Providers in China

    Bristol-Myers Squibb (B-MS) on Monday agreed to pay more than $14 million to the Securities and Exchange Commission (SEC) to settle charges that its joint venture in China made cash payments and provided other benefits to health care providers (HCPs) at state-owned and state-controlled hospitals in exchange for prescription sales. The payment comes as SEC found B-MS violated the Foreign Corrupt Practices Act (FCPA) and reaped more than $11 million in profits from its mis...
  • 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...