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  • Regulatory NewsRegulatory News

    FDA seeks withdrawal of Makena, generics from market

    The US Food and Drug Administration (FDA) on Monday proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a postmarket study failed to confirm clinical benefit.   The request comes nearly a year after FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee recommended that the agency withdraw its approval for the drug and more than nine years after it received accelera...
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    FDA announces all-time low rates for FY2021 PRVs

    The US Food and Drug Administration (FDA) has announced historic low rates for the fiscal year 2021 fees to use its three priority review voucher programs.   For the upcoming fiscal year, the rate to use a material threat medical countermeasure (MCM) priority review voucher (PRV) is an all-time low $1,360,879. The PRV rate is the same for the rare pediatric disease and rare tropical disease voucher programs, according to Federal Register announcements.   This figur...
  • Regulatory NewsRegulatory News

    Misleading ads for asthma, weight loss meds garner warning letters

    Emails from an executive and sales staff falsely touted an inhaled steroid preparation as a treatment for COVID-19, prompting a warning from the branch of the US Food and Drug Administration (FDA) that oversees drug promotion. This communication, together with one directed to the application holder of a weight loss medication, made the third and fourth warning letters of the year issued by FDA's Office of Prescription Drug Promotion (OPDP).    In a 24 September let...
  • ReconRecon

    Recon: BMS to buy MyoKardia for $13.1B; EMA’s PRAC reviews possible kidney injury from remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Warp Speed's focus on vaccines may have shortchanged antibody treatments ( Politico ) Bristol to Pay $13.1 Billion for Heart-Drug Maker MyoKardia ( WSJ ) ( STAT ) ( FT ) ( Press ) White House Takes Issue With FDA’s Plans for Authorizing a Covid-19 Vaccine ( WSJ ) Biotech Industry Pushes Trump Administration to Release New Vaccine Guidelines ( NYTimes ) Memo d...
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    Report: FDA REMS program ineffective at curbing opioid misuse

    The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but that program is a poor tool for fighting the opioid epidemic, the Health and Human Services Office of the Inspector General concluded in a new report .   The REMS program is a long-standing drug safety program that has allowed the FDA to require manufacturers to implement ...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...
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    Consider a variety of endpoints for OUD treatments: FDA guidance

    Consider a variety of endpoints for OUD treatments: FDA guidance   A new final guidance document from the US Food and Drug Administration (FDA) gives drugmakers considerations for choosing endpoints for new medications to treat opioid use disorder (OUD).   “We recognize that there’s great interest in developing new treatment options that result in meaningful outcomes, said FDA Commissioner Stephen Hahn, MD, in announcing the final guidance, which has only minor c...
  • ReconRecon

    Recon: Breakthrough status for Farxiga; 'Transformative' Zolgensma data

        Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Tests Positive for Coronavirus ( WSJ ) ( NYT ) ( Washington Post ) ( CNBC ) ( Politico ) ( BBC ) ( Reuters ) First doses of US vaccine must be strictly rationed, says report ( Financial Times ) Dr. Scott Gottlieb sees antiviral remdesivir as best coronavirus treatment should Trump need one ( CNBC ) Where was Trump — and who was he with ...
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    RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide

    Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global...
  • Feature ArticlesFeature Articles

    Implementing the MDR: Slowing down on the homestretch?

    With the most recent delay to 26 May 2021 as the date of application for the European Medical Device Regulation (MDR) 1 still fresh in our minds, 2 many wonder if it is a matter of time before we hear about the next extension. It’s a valid question, as many manufacturers still have a long way to go until they are fully compliant with the new rules and expectations. However, it does not do justice to the differences between the circumstances at the start of the first wave...
  • Regulatory NewsRegulatory News

    FDA gives draft adjuvant trial guidance for RCC, bladder cancer

    Two new draft guidances from the US Food and Drug Administration give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers. The first of the guidances released on 1 October addresses adjuvant treatment for bladder cancer, and the other addresses adjuvant treatment of renal cell carcinoma (RCC).   “Currently, there is significant variability in the design, conduct, and analysis of clinical trials” that examine adjuvant ...
  • Regulatory NewsRegulatory News

    MHRA issues post-transition orphan, Northern Ireland supply guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.   The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidances , ...