Agency IQ

JULY 28, 2023

In a related development, this week, a new FDA guidance document to support development of medical devices to treat opioid use disorder (OUD) inched closer to release. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ]. Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. Read Agency IQ’s complete breakdown of the FDA’s PHE guidance documents here.]

FDA 40

FDA Clinical Trials Vaccine Trials 40

Agency IQ

FEBRUARY 23, 2024

The discussions in this workshop incorporated the content of a draft guidance document on the topic released by the FDA in 2023, as well as the information shared in another series of workshops co-hosted by the FDA and the American Society of Clinical Oncology (ASCO), which occurred in 2022 and 2023.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. At the start of the year, FDA published a guidance document, not specific to oncology, on the use of external controls. What’s ahead?

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. In addition, CDER’s guidance agenda only reflects documents that are under development.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Once metabolized, which occurs quickly with a half-life of approximately 1.5

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40