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  • Regulatory NewsRegulatory News

    FDA: US Heparin Supply Not Impacted by African Swine Fever in China

    With shortage concerns looming, the US Food and Drug Administration (FDA) on Monday said that the US heparin supply is not being impacted by the African swine fever in China. “The majority of manufacturers reported no such issues related to African swine fever,” FDA said after reaching out to heparin suppliers. “FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves.” The update from FDA follows a letter sent in ...
  • Regulatory NewsRegulatory News

    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
  • Regulatory NewsRegulatory News

    FDA Raises Concerns With 505(q) Petitions

    In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns. “FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency sa...
  • Regulatory NewsRegulatory News

    FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

    The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA Reiterates Concerns on Citizen Petitions Delaying Drug Approvals

    Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions. In 2015, FDA notes that it ap...
  • Feature ArticlesFeature Articles

    Integrating FDA Meetings into a Medical Device Regulatory Strategy

    This article focuses on the strategic use and suitability of a Q-Submission program. Introduction An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the...
  • Regulatory NewsRegulatory News

    FDA, Industry See Progress in MDUFA IV Negotiations

    At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction. The negotiations center on the use of a system whereby medical device companies pay fees to FDA to register their establishments and list their devices with the agency. The fees help FDA increase the ef...
  • Regulatory NewsRegulatory News

    In Petition to FDA, AbbVie Argues Biosimilars Need Distinctive Labeling

    "Biosimilars are not generic drugs and should not be labeled like generic drugs," US pharmaceutical giant AbbVie argues in a new Citizen Petition sent to the US Food and Drug Administration (FDA) this week. The petition focuses on the labeling requirements for biosimilar products under the 2010 Patient Protection and Affordable Care Act (PPACA) , otherwise known as Obamacare. The law established for the first time an approval pathway—the 351(k) pathway—for biosimilar dr...
  • Regulatory NewsRegulatory News

    FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

    A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...
  • Regulatory NewsRegulatory News

    FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

    The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola —the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month. Dangerous Substances In a statement released to the press on 16 July 2014, the agency confirmed that it found hundreds—327 to be exact— of "carefully packaged v...
  • FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

    US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval. Background: FDAAA In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA) , which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is...