• 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...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Updated COVID vaccine guidance, Senate to hold user fee hearing

    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 updates to FDA’s guidance on developing COVID-19 vaccines and look forward to next week’s Senate hearing on reauthorizing FDA’s user fee programs.   The big news we’re closing out the week with is FDA’s latest update to its COVID-19 vaccine emergency use authori...
  • 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...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Congress takes up FDA bills; CDRH leans in for more authority on shortages

    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 the US House and Senate held hearings on some major pieces of health care legislation, the FDA drafted two guidances on human gene therapy products and chimeric antigen receptor (CAR) T cell products, and vaccine manufacturers have submitted applications to authorize another C...
  • This Week at FDAThis Week at FDA

    This Week at FDA: MDUFA V deal takes shape; E&C to review FDA bills next week

    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 of the week is that FDA and industry have reached a tentative deal on the next iteration of the Medical Device User Fee Amendments (MDUFA V). Also, this week Congress passed its long-delayed FY2022 omnibus spending package , the FDA has issued a number of class I r...
  • This Week at FDAThis Week at FDA

    This Week at FDA: HHS delays SUNSET rule, FDA begins release of Comirnaty review docs, 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 saw the Department of Health and Human Services (HHS) delay the effective date of a controversial Trump-era rule. We also read that FDA has begun releasing documents related to its review of the Pfizer-BioNTech COVID-19 vaccine Comirnaty per a recent court ruling and glance ...