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    Brexit Withdrawal Signed Ahead of UK’s 31 January Departure

    Presidents of the European Commission and European Council and UK Prime Minister Boris Johnson on Friday signed a withdrawal agreement that will see the UK continue to follow EU rules through the end of the year while seeking a deal for future ties with the EU.   The European Parliament is scheduled to vote on the deal on 29 January. The agreement is expected to sail through the European Parliament after its Constitutional Affairs Committee voted in favor of the agre...
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    FDA Finalizes 2018 Guidance on Use of Minimal Residual Disease

    The US Food and Drug Administration (FDA) on Friday finalized guidance to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials for treating specific hematologic malignancies. The 18-page guidance discusses technology that can detect the persistence of malignancy at, what FDA says are, "orders of magnitude below the limit of conventional morphologic detection," which has a threshold limit of one tumor cell in 100 cells. This lev...
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    Gilead Claims Truvada Patents in HHS’ Complaint are Invalid

    Back in November, the US Department of Health and Human Services (HHS) took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP). But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they a...
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    Recon: Insys Founder Kapoor Sentenced to 5.5 Years Over Opioid Kickback Scheme; Roche’s Tecentriq Fails in Phase III Urothelial Cancer Trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Epizyme prices rare tissue cancer treatment at $15,500 a month ( Endpoints ) ( FDA ) ( Press ) Insys founder gets 5½ years in jail for his role in fentanyl prescription scheme ( STAT ) ( Reuters ) ( NYTimes ) Broken US System Has Pharma on Edge Even as Stocks Hit Highs ( Bloomberg ) IPI rule may be too little, too late for Trump ( Politico ) Drug To Prevent P...
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    Regulatory Affairs Consultants: Who Needs Them and Why

    This article discusses employing regulatory affairs consultants and offers advice on who needs consultants and why, the “dos and don’ts” of finding, managing and maintaining consultants, how to choose the right consultant with the right background and expertise for the needed tasks and consultant service and pricing models. This article was adapted from a RAPS Convergence presentation held in Philadelphia 21-24 September 2019.   Introduction   The advent of today’s...
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    MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More

    As device firms ramp up their final preparations ahead of the 26 May application date for the Medical Devices Regulation (MDR), the European Commission’s Medical Device Coordination Group (MDCG) is planning to host 14 different meetings between now and then. Kicking off the meetings is a workshop on 3 February on sufficient clinical data, which will likely be of interest to device firms because of the heightened requirements for providing such data for an increasing num...
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    Drug-Drug Interactions: FDA Issues Guidance on Clinical, In Vitro Studies

    The US Food and Drug Administration (FDA) on Thursday finalized two guidances providing recommendations to drugmakers on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing.   “Together, the two final guidances describe a systematic risk-based approach to evaluation and communication of DDIs,” FDA writes.   The two guidances finalize draft versions released in 2017 and have been revised to clarify their scope, ...
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    [Updated] The Changing Regulatory Landscape for Insulin

    This article discusses the rising price of insulin and its historical context. The authors review and analyze legislative efforts to keep prices reasonable for patients and review the various barriers to making insulin less expensive. They conclude by looking at the potential effects of regulatory changes by FDA to transition insulin from regulation under the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to the Public Health Service Act ( PHS Act ),* and suggest tha...
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    FDA Warns of Cyber Risks With Certain GE Devices

    The US Food and Drug Administration (FDA) on Thursday warned that several GE Healthcare devices could be hacked to silence alarms connected to the devices, generate false alarms and interfere with alarms of patient monitors connected to these devices. The warning concerns GE’s Clinical Information Central Stations and Telemetry Servers, which FDA says are mostly used for displaying information such as a patient’s temperature, heartbeat and blood pressure, as well as mon...
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    FDA Seeks Help Using Algorithms to Detect Adverse Event Anomalies

    As it becomes more difficult for the US Food and Drug Administration (FDA) to decipher when a series of adverse events could actually be a sign of a more significant problem, the agency is calling on the public to develop computational algorithms for the automatic detection of adverse event anomalies using publicly available data. The current system of tracking adverse events is passive, in that patients, patient guardians, health care providers and manufacturers submit...
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    RAPS AnnouncementsRAPS Announcements

    RAPS 2020 Board Begins Term, Welcomes Trautman, Pokrop and Hoekstra

    The RAPS board of directors of officially began its 2020 term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, is serving his second year as chairman. Boyer’s term was extended from one to two years when the RAPS board officers’ structure was changed by member vote in November. The term of the board president was also increased to two years, and the president-elect position was eliminated. “I am honored to have the...
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    FDA, MHRA Officials Stress the Criticality of Data Integrity in Clinical Trials

    As clinical trial methodologies and new technologies are deployed, data integrity and the safety of clinical trial participants remain at the forefront of regulatory oversight, officials from the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote in an article published this week in Clinical Pharmacology & Therapeutics . International regulatory collaboration on good clinical practice (GCP) has become cri...