• Regulatory NewsRegulatory News

    Sanofi, CDC and FDA Work to Avoid Yellow Fever Vaccine Shortage

    To head off an impending shortage of YF-VAX, the only US-licensed vaccine for yellow fever, Sanofi Pasteur, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are working to provide travelers with an alternative vaccine. In the coming months, Sanofi will begin importing Stamaril, a yellow fever vaccine developed from the same substrain as YF-VAC, and will distribute it to select clinics around the US. While Stamaril is ...
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    FDA Approved Nearly All Expanded Access Requests in FY2016

    The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week. Through FDA's expanded access program, the agency allows patients with serious or life-threatening diseases to access unapproved drugs. Under the program, physicians can request access to a drug for individual patients or a group of patients under an expanded access investigational ne...
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    FDA Considers Creating New 'Office of Patient Affairs'

    As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inqu...
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    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
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    21st Century Cures Act Deadlines Approach in March and June

    The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...
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    EU Parliament Committee Backs Report to Increase Access to Medicines

    The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions. The draft , which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of differ...
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    FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer

    The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance . With the approval of the new labeling, FDA said it has also closed its investigation of a trade complaint , initially filed as a citizen petition , against Bayer concerning the device. FDA spokesperson Angela Stark told Focus the investigation included a review of E...
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    BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday accepted Bristol-Myers Squibb's Opdivo (nivolumab) to its early access to medicines scheme (EAMS) to treat relapsed or refractory Hodgkin's lymphoma. Previously, MHRA granted access to Opdivo under EAMS for patients with certain types of lung cancer, kidney cancer and melanoma. Background In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially...
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    FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

    The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure. While the final guidance retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated. However, these changes are unlikely to settle concerns from patients who say they have been harmed by ...
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    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
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    Patient Registries: EMA Wants to Make Better Use of Medicines Data

    The European Medicines Agency (EMA) on Friday is hosting a workshop to discuss ways to better use existing patient registries that collect high-quality data on drugs in clinical practice. Patient registries collect information over time on patients with a particular disease or who receive particular treatment during both pre-authorization and post-authorization periods. Such data can complement data from other sources to more effectively monitor drug risks and benefits. ...
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    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...