Drug Target Review

AUGUST 7, 2024

The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

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Drug Development Clinical Pharmacology Clinical Trials Drugs 59

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) submission for Bendeka included a complete chemistry, manufacturing, and controls (CMC) package, but relied on the drug master file (DMF) for Treanda. The overall development strategy for GT123 was to include a complete CMC package. daily versus four times daily dosing). Pediatric considerations.

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Drugs Packaging Clinical Pharmacology Small Molecule 52

Alta Sciences

SEPTEMBER 20, 2023

Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences. “We are very pleased to be working with Virpax again and are satisfied with the trajectory our studies have taken. The final step for this program will be a bioanalytical sample analysis.

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Virus Clinical Pharmacology Drugs FDA Approval 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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Science FDA Trials Clinical Pharmacology 40

Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Featuring previous research by Kedest Tadesse, Kari Oakes and Alec Gaffney.

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FDA Biosimilars Science Drugs 52

Agency IQ

JUNE 16, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda.

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Regulations FDA Science Production 40