• Regulatory NewsRegulatory News

    VRBPAC recommends addition of Omicron-component to future boosters

    A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated strain composition in hopes that vaccine targeting a more recent strain of the virus will be more effective.   FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 28 June to discuss whether the a...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Spring regulatory agenda, upcoming guidances, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.   Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will ...
  • ReconRecon

    Recon: Moderna touts bivalent booster’s response against Omicron subvariants; EU to raise investment in Latin American drug manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna booster candidate shows strong response against Omicron subvariants ( Reuters ) Moderna CEO: COVID variant vaccine to be ready for shipping in August ( Reuters ) Omicron-specific COVID vaccines on the horizon, Pfizer chief says ( Reuters ) More vulnerable people receiving fewer COVID pills - U.S. study ( Reuters ) FDA to Order Juul E-Cigarettes Off U....
  • Regulatory NewsRegulatory News

    FDA authorizes Pfizer, Moderna vaccines for youngest children

    The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.   This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Mode...
  • ReconRecon

    Recon: Moderna to study COVID vaccine in babies 3 to 6 months of age; Walgreens enters clinical trial business

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Commissioner Admonishes Health Care Stakeholders To Know Agency Better, Help More ( MedtechInsight ) Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months ( WSJ ) FDA Panel Recommends Pfizer and Moderna Vaccines for Youngest Children ( NYTimes ) ( STAT ) Abbott Baby Formula Plant Again Stops Production, This Time Because of Flooding ( NYT...
  • Regulatory NewsRegulatory News

    VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children

    On Wednesday, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of amending FDA’s emergency use authorization (EUA) for Moderna’s two-dose vaccine to include children 6 months through 5 years of age. The committee voted separately in favor of recommending to amend Pfizer’s EUA for its vaccine and authorize use of a three-dose vaccine for children 6 months through 4 years of age.   In a 21-0 v...
  • ReconRecon

    Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children ( WSJ ) ( STAT ) ( Reuters ) US pivots to ‘harm reduction’ after 107,000 overdose deaths last year ( FT ) Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA ( Endpoints ) Bristol Myers asks Supreme Court to revive $1.2 bln cancer-drug patent win (...
  • Regulatory NewsRegulatory News

    VRBPAC unanimously backs Moderna vaccine for children 6 and up

    The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.   The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adoles...
  • ReconRecon

    Recon: FDA approves Lilly’s alopecia drug; EU states pressure Pfizer to cut unneeded COVID vaccine supplies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers weigh Moderna COVID vaccine heart risk for young men ( Reuters ) FDA Advisers Considering Moderna’s Covid-19 Vaccine for Ages 6 to 17 ( WSJ ) Alnylam wins FDA approval of rare disease drug in step toward profitability ( BioPharmaDive ) Amylyx's ALS drug would be more cost effective if priced around $170,000, pricing watchdog says ( Reuters ) ...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
  • Regulatory NewsRegulatory News

    FDA authorizes second round of mRNA boosters for older and immunocompromised people

    The US Food and Drug Administration (FDA) on Tuesday signed off on a second round of COVID-19 vaccine booster shots for immunocompromised individuals and people 50 years of age and older.   The agency said the boosters can be administered four months after receiving the first booster dose of any authorized or approved COVID-19 vaccine in both populations.   The populations covered by the latest authorizations differ from those sought by the two vaccine makers. Pfiz...
  • This Week at FDAThis Week at FDA

    This Week at FDA: MDUFA’s turn in Congress, another COVID vaccine adcomm, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we learn that the House Energy and Commerce committee will finally take up legislation to reauthorize the Medical Device User Fee Amendments (MDUFA) next Wednesday. Plus, we look at upcoming developments on COVID-19 vaccines and a much-anticipated advisory committee meeting o...