Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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FDA Science Regulations Clinical Trials 40

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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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. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

JUNE 16, 2023

0910-AH55 December 2023 September 2023 Proposed Rule Clinical Holds in Medical Device Investigations The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. the drug and device) of the combination product.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

OCTOBER 27, 2023

the drug and device) of the combination product.

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Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”

Biosimilars 40

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA 40

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Agency IQ

FEBRUARY 15, 2024

Priority A List. The guidance will provide a comprehensive, systematic and stepwise approach with examples, when applicable, to illustrate how to make this determination. The guidance will cover best practices for information submission and other communications.

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Agency IQ

DECEMBER 1, 2023

The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices. the drug and device) of the combination product.

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Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

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Drug Target Review

NOVEMBER 27, 2024

This article highlights the benefits of leveraging advanced biomarker analysis methods, and how they ultimately save drug developers time and money by getting one step ahead of regulatory requirements. The global biomarker discovery outsourcing service market was estimated at $2.7 Clinical Pharmacology & Therapeutics.

Drug Development 52

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Agency IQ

JULY 12, 2024

Proposed Rule Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition December 2024 This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. and the E.C.

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