• This Week at FDAThis Week at FDA

    This Week at FDA: User fee timeline, bivalent boosters, 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. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.   Alongside the recommendation, FD...
  • 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 ...
  • This Week at FDAThis Week at FDA

    This Week at FDA: FDA authorizes COVID vaccines for youngest children; Congress holds budget, pandemic hearings

    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. It was budget week on the Hill and with that, we saw a number of hearings related to the FY2023 budget and pandemic funding. The biggest news of the week is FDA's  authorization of two mRNA COVID-19 vaccines for children as young as 6 months of age. The authorizations comes after months...
  • Regulatory NewsRegulatory News
    This Week at FDAThis Week at FDA

    This Week at FDA: User fee moves, COVID vaccine updates, 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. There was a lot going on this week on the COVID-19 vaccines front. We made it through the first of several Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings this month on COVID-19 vaccines and have two days of meetings to look forward to next week. We also lear...
  • Regulatory NewsRegulatory News
    This Week at FDAThis Week at FDA

    This Week at FDA: Senate user fee markup, Novavax briefing docs, and CDRH withdraws a PHE guidance

    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 learned that the Senate Health, Education, Labor & Pensions (HELP) committee will markup its version of the FDA user fee reauthorization bill next week. We also got a glimpse at the briefing documents for FDA’s upcoming advisory committee meeting to review Novavax’s COVID-19...
  • Regulatory NewsRegulatory News
    This Week at FDAThis Week at FDA

    This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official

    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, FDA announced the dates for three upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to review the Moderna and Pfizer/BioNTech vaccines for younger children, Novavax’s COVID-19 vaccine and SARS-CoV-2 strain composition for modified vaccines. ...
  • This Week at FDAThis Week at FDA
    Regulatory NewsRegulatory News

    This Week at FDA: House advances user fee bill, FDA’s enterprise modernization ambitions, and another 510(k) pilot

    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. It was a busy week for FDA on the Hill again, with FDA Commissioner Robert Califf testifying before the House Appropriations committee on Thursday and the House Energy & Commerce committee voting unanimously to send FDA user fee and reform legislation to the House floor.   On Thursday...
  • This Week at FDAThis Week at FDA
    Regulatory NewsRegulatory News

    This Week at FDA: House holds user fee markup, CDER’s ARC for rare diseases

    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 saw legislation to reauthorize the FDA’s user fee programs advance in the House. We also learned that FDA is standing up a new program to speed the development of treatments for rare diseases with unmet medical need. Plus, we take a look at a new GAO report on FDA’s efforts ...
  • This Week at FDAThis Week at FDA

    This Week at FDA: What we learned at MedCon, looking to RAPS Euro Convergence 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’ve been covering the annual MedCon 2022 conference, presented by the AFDO/RAPS Healthcare Collaborative. At the meeting, Jeff Shuren, FDA’s device center chief, said the agency is planning to ease back into holding pre-submission meetings for all products after hitting t...
  • This Week at FDAThis Week at FDA

    This Week at FDA: A busy week on the Hill, VRBPAC’s June meeting bonanza, 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 was a busy week for FDA in Congress, with hearings in both chambers touching on FDA’s user fee programs, FY2023 budget request, and more. We also saw FDA release a tentative schedule for several upcoming advisory committee meetings to discuss COVID-19 vaccines. Plus, we learned that ...
  • This Week at FDAThis Week at FDA

    This Week at FDA: COVID breathalyzer gets EUA, upcoming adcomms, 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, FDA authorized the first COVID-19 diagnostic that uses breath samples to detect chemical compounds associated with SARS-CoV-2 infection. We also learned that Pfizer and BioNTech plan to submit an emergency use authorization (EUA) request for a booster dose of their vaccine for ...
  • This Week at FDAThis Week at FDA

    This Week at FDA: MDUFA V public meeting, CMS’ Aduhelm decision, 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 look at upcoming FDA meetings to discuss the Medical Device User Fee Amendments (MDUFA V) program and a US-Canada joint consultation on several International Council for Harmonisation (ICH) guidelines. We also look at the Centers for Medicare and Medicaid Services (CMS) co...