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    FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

    High field strength magnets in some consumer electronic devices may trigger “magnet mode” in certain implanted medical devices such as pacemakers and cardiac defibrillators, the US Food and Drug Administration said on Thursday.   Many implanted electronic medical devices feature a magnet mode to allow the safe operation of the device during medical procedures such as an MRI scan. While in magnet mode normal device operations are suspended and the mode is typically enga...
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    Recon: FDA releases hundreds of pages of Trump-era emails; Biogen gene therapy misses study goals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Internal Trump-era emails reveal a plethora of celebs, companies vying for FDA’s attention ( Endpoints ) ( Politico ) ( FDA ) Biogen's experimental eye treatment fails to meet study goal ( Reuters ) ( Endpoints ) Fully vaccinated people can shed their masks in most places - CDC ( Reuters ) ( STAT ) Adolescents Can Get Routine Immunizations With Their COVID Sho...
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    House Dems press Becerra on FDA LDT oversight

    In a letter to Department of Health and Human Service (HHS) Secretary Xavier Becerra earlier this week, top Democrats on the House Energy and Commerce Committee pressed the health secretary to reverse a Trump-era policy that removed laboratory developed tests (LDTs), including those for COVID-19, from US Food and Drug Administration (FDA) oversight.   “Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliabili...
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    Recon: FDA approves Heron’s non-opioid anesthetic; Poll suggests low public trust in US health institutions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ) US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ) Covid vaccines may not protect people with immune disorders. NIH trial seeks answers. ( NBC ) Poll Finds Public Health Has A Trust Problem ( NPR ) ( RWJF ) Third ti...
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    Recon: Emergent execs to testify before house panel; ACIP weighs Pfizer vaccine in adolescents

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID-19 vaccine works for adolescents, CDC panel told ( Reuters ) Pelosi drug price plan threatened by centrist defections ( Politico ) ( STAT ) Illumina CEO insists GRAIL merger will be good for competition, and ultimately, patients ( STAT ) AbbVie Slapped With Suit From Would-Be Humira Rival ( Law360 ) ( Fierce ) Sanofi is accused of ‘widespread des...
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    FDA finalizes QIDP Q&A guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.   The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designati...
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    Recon: MiNA enters $1.25B partnership with Eli Lilly; EU launches new lawsuit against AstraZeneca in vaccine spat

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15 ( NYTimes ) ( Politico ) ( FDA ) US children ages 12 to 15 could begin COVID-19 vaccinations Thursday ( Reuters ) Novavax delays timelines for COVID-19 vaccine regulatory filings, production ( Reuters ) ( The Hill ) Inovio to start global late-stage COVID-19 vaccine trial this summer ( Reuters ) Flo...
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    FDA authorizes Pfizer-BioNTech vaccine in children 12-15

    The US Food and Drug Administration (FDA) on Monday authorized Pfizer and BioNTech’s COVID-19 vaccine for use in adolescents 12 to 15 years of age.   "The FDA's expansion of the emergency use authorization [EUA] for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock in a statement. "Today's action allows for a younger popul...
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    Shuren updates on inspections, ISO 13485 and MDUFA V

    Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.   The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiolog...
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    Recon: Lilly signs deals to boost India supply of antibody drugs; Inovio says COVID vaccine safe, effective in Ph. 2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial ( Reuters ) AstraZeneca weighs seeking full approval for Covid shot, skipping EUA ( WSJ ) ( Reuters ) Novavax not expected to seek COVID vaccine authorization until June at the earliest ( Washington Post ) Biden administration signals that FDA may allow abortion pill access via mail even...
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    Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ) Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ) How Big Pharma finds sick users on Facebook ( TNW ) ( Ars ) Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ) The US opened pandora’s box on IP...
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    EC strategy aims for 3-5 new COVID therapeutics by year end

    To support the development of therapeutics for COVID-19, the European Commission on Thursday announced a new strategy intended to bring at least three to five new COVID-19 therapeutics to market this year.   The strategy, which includes more than €140 million in funding, aims to streamline the development of promising new medicines and ensure their speedy rollout across the EU, complementing the strategy the Commission deployed for COVID-19 vaccines last year. (RELATED...