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It’s About Time: FDA’s Proposed Rule to Amend Prior Notice Regulations

FDA Law Blog: Biosimilars

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. The requirement for prior notice originates in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). By Sophia R.

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Analysis Chemical Thank You The 103 regulations the EPA is currently working on

Agency IQ

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Chinese Government Arrests GenScript and Legend Biotech Founder for Smuggling

The Pharma Data

Zhang’s arrest was for “the suspected offense of smuggling goods prohibited by the import and export regulations under the laws of the PRC,” according to a GenScript statement. Human genetic goods are tightly regulated by the Chinese government. Zhang had served as the chairman of board of directors of Legend Biotech since 2015.

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Women in STEM: An Inspiring Journey with Dr Jo Brewer

Drug Target Review

It set a precedent with regulators as to what is expected in some instances. Regarding the NY-ESO programme that we worked on, I started work on that in 2002 before we even knew that we were going to do cell therapy. Numerous organisations are adopting many of the techniques we developed considering that incident.

Therapies 115
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New targeted therapies show promise in lung cancer treatment

Drug Target Review

Landscape of clinical drug development of ADCs used for the pharmacotherapy of cancers: an overview of clinical trial registry data from 2002 to 2022. Engineering sites on the antibody to enable specific and consistent attachment of the cytotoxic drug to achieve an optimal drug-to-antibody ratio (DAR). BMC Cancer. 2024;24(1):898.

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Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.