Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. That said, BT would be a lagging indicator since it can be granted so early in the development process. Fewer meetings – more approvals.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. That means we could see an updated agenda in late June or early July, giving us a better sense of what FDA is working on and when it hopes to complete its rulemaking.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. In 2021, the FDA issued draft guidance on Credibility of Computational Modeling & Simulation (CM&S) in Medical Device Submissions.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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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. Earlier this year, the FDA reported that, for FY 2021, 31% of all required post-marketing studies had not yet been completed and were off-schedule for future completion. Read the AgencyIQ analysis here.

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The Pharma Data

FEBRUARY 8, 2021

i] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #9; Oral Abstract Session: Prostate Cancer, February 11, 12:45 PM-2:00 PM EST). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83];

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

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The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics.

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Agency IQ

DECEMBER 11, 2023

For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.” In 2021, FDA’s efforts on dose optimization came to the forefront with the announcement of Product Optimus.

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Agency IQ

OCTOBER 27, 2023

Circuit vacated the final rule in 2021. FDA finalized a ban on these devices in 2020, but the D.C. FDA previously determined that the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling.

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Agency IQ

DECEMBER 1, 2023

Circuit vacated the final rule in 2021. FDA finalized a ban on these devices in 2020, but the D.C. FDA previously determined that the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling.

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