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AZVUDINE

New Drug Approvals

Detailed numbers are provided by Genuine in the slides and the medication package insert. [14] 24] Roche held one 2002 patent, CNA028118480A (CN1516590A), over the broader class of 4′-substituted nucleotides. Common (> 1%) side effects include nausea, elevated blood lipids, fever, insomnia, tiredness, and diarrhea.

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

Agency IQ

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Analysis One wonders what role the envisioned ECHA basic regulation will have in supporting this reform package.

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Article FDA Thank You Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Agency IQ

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

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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

There are two codes that all 49 Notified Bodies received designation to – devices with a measuring function (MDS 1010) and devices that require packaging/labeling (MDT 2011).

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Beyond Steel Tanks

Codon

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. But despite the law’s age, it is not yet fully operational.

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

Once E2D(R1) has been finalized following comments received during public consultation, the note stated that “the final changes will be published via the E2B(R3) Implementation Guide package and ICH E2B(R3) Questions and Answers document.” This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements.

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