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Building Korro Bio: A CEO’s Perspective on Innovation and Risk Management

LifeSciVC

This ability to activate pathways could be possible for almost all proteins, however the biggest differentiation was to consider areas that were hard to drug – transcription factors, ion channels, intracellular proteins, etc. Is it more important to have a clinical meaningful drug candidate OR convenience?

RNA 67
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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Early FDA Feedback with Type D Meetings

The Premier Consulting Blog

The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. Prescription Drug User Fee Act (PDUFA) VII The Prescription Drug User Fee Act (PDUFA VII) is a law that was signed and took effect on September 30, 2022.

FDA 52
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Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting

Alta Sciences

It owned the societal name of the Canadian Association for Research on Drug Safety. As experts in early-phase drug development , from discovery through Phase II clinical research , we at Altasciences can share with STC members our accumulated knowledge and experience, and provide mentorship for future toxicologists.

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How Many Clinical Trials Are Run by CROs?

Vial

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

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Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Agency IQ

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

Science 40
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Article FDA Thank You Diagnostics landscape analysis: Key issues and a look ahead at 2024

Agency IQ

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA 40