2011 Packaging Therapies 
Agency IQ
APRIL 12, 2024
Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?
Agency IQ
JUNE 7, 2024
Active medical devices fall into these categories: MD 1100 general active medical devices, MD 1200 devices for imaging, MD 1300 monitoring devices, MD 1400 devices for radiation and thermo therapy. Series AIMD 0100 describes all active implantable device types.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Broad Institute
JANUARY 14, 2025
When I received my genetic test report in 2011, the world had never heard of base editing. Building on previous work by the vector-engineering lab of Ben Deverman at the Broad, the team developed a pair of adeno-associated viruses (AAVs) to package and deliver the base-editing machinery to brain cells. Nature Medicine.
Codon
APRIL 9, 2024
However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. With help from the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), artemisinin-based combination therapy became much more economically accessible worldwide.
Agency IQ
JULY 22, 2024
As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database. For a look at some other trends, see Agency’s Fiscal Year 2023 in Review ].
Agency IQ
OCTOBER 6, 2023
As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Data on these novel approvals is published throughout the year by both CDER and CBER.
The Pharma Data
AUGUST 3, 2021
Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS received accelerated approval based on overall response rate and duration of response.
Expert insights. Personalized for you.
40 
Let's personalize your content